Vivistim Paired VNS System

Identity

Manufacturer

MicroTransponder

Model number

—unknownUpdated: 2026-05-04

Codename

—unknownUpdated: 2026-05-04

Aliases

Vivistim, MicroTransponder VivistimverifiedSources (2)

1. Vivistim — official sitehttps://www.vivistim.com
2. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Generation

—unknownUpdated: 2026-05-04

Country of origin

USverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Released

2021-08-27verifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Announced

—unknownUpdated: 2026-05-04

Discontinued

—unknownUpdated: 2026-05-04

Status

shippingverifiedSource

1. Vivistim — official sitehttps://www.vivistim.com

Updated: 2026-05-04

Classification

Invasiveness

invasiveverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Modalities

VNSverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Primary modality

VNSverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Direction

writeverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Categories

medical-implant, stimulation, therapeuticverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Form factor

implantverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Use cases

treatment of moderate-to-severe upper-extremity motor deficits in chronic ischemic stroke, vagus nerve stimulation paired with physical / occupational therapyverifiedSources (2)

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27
2. NeurologyLive — FDA approves Vivistim VNS for strokehttps://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits2021-08-30

Updated: 2026-05-04

Target users

neurosurgeon, therapist, patient-strokeverifiedSources (2)

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27
2. NeurologyLive — FDA approves Vivistim VNS for strokehttps://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits2021-08-30

Updated: 2026-05-04

Electrodes

Stimulation

Capable

YesverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Connectivity

Protocols

proprietary-rfverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Bluetooth

—unknownUpdated: 2026-05-04

Bluetooth profiles

—unknownUpdated: 2026-05-04

Concurrent mode

single-onlyverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Encryption (transit)

—unknownUpdated: 2026-05-04

Pairing methods

—unknownUpdated: 2026-05-04

Cloud sync

—unknownUpdated: 2026-05-04

Offline recording

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Power

Sources

non-rechargeableverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Battery life (active)

—unknownUpdated: 2026-05-04

Charging port

—unknownUpdated: 2026-05-04

Charging time

—unknownUpdated: 2026-05-04

Battery replaceable

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Notes

Primary cell; generator replacement surgery at end-of-life.verifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Physical

Weight

—unknownSource

1. v0 said 13 g; not pinned in primary sources

Updated: 2026-05-04

Dimensions

—unknownSource

1. v0 listed 42 × 33 × 6 mm; not pinned in primary sources

Updated: 2026-05-04

Materials

titaniumverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Sizes

—unknownUpdated: 2026-05-04

Head circumference

—unknownUpdated: 2026-05-04

Operating temp

—unknownUpdated: 2026-05-04

Compute

Has onboard computer

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Operating systems

custom-firmwareverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Primary OS

custom-firmwareverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Edge ML accelerator

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Root access

noneverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

App sandbox

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

3rd-party apps allowed

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Notes

Stimulation triggered by therapist via paired wireless transmitter during rehab task practice.verifiedSources (2)

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27
2. NeurologyLive — FDA approves Vivistim VNS for strokehttps://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits2021-08-30

Updated: 2026-05-04

Software & data

Mobile app

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Cloud platform

—unknownUpdated: 2026-05-04

Offline mode

YesverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Subscription required

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Raw data access

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Export formats

—unknownUpdated: 2026-05-04

LSL support

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Data ownership

manufacturerverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Apps

Vivistim Programmer (clinician), Vivistim Therapist Wireless TransmitterverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

SDK & developer access

Has SDK

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Open source

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Languages

—unknownUpdated: 2026-05-04

Web Bluetooth

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Raw sample access

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

BCI paradigms

—unknownUpdated: 2026-05-04

3rd-party integrations

—unknownUpdated: 2026-05-04

Docs

—unknownUpdated: 2026-05-04

Capabilities

Attention / focus

—unknownUpdated: 2026-05-04

Meditation / calm

—unknownUpdated: 2026-05-04

Neurofeedback

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Meditation coaching

—unknownUpdated: 2026-05-04

Sleep tracking

—unknownUpdated: 2026-05-04

Regulatory & clinical

FDA status

pmaverifiedSources (2)

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27
2. FDA PMA P210007 — Summary of Safety and Effectiveness Datahttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007B.pdf2021-08-27

Updated: 2026-05-04

CE mark

—unknownSource

1. v0 said true; not pinned in primary MicroTransponder sources

Updated: 2026-05-04

Certifications

FDA PMA P210007, FDA Breakthrough DeviceverifiedSources (2)

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27
2. Vivistim — official sitehttps://www.vivistim.com

Updated: 2026-05-04

Prescription required

YesverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Pediatric approved

NoverifiedSource

1. FDA PMA P210007 approval letter — Vivistim Paired VNS Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf2021-08-27

Updated: 2026-05-04

Pricing & availability

MSRP

—unknownSource

1. v0 said ~$35k hardware-only; implant pricing is hospital-negotiated, not publicly listed

Updated: 2026-05-04

Current price

—unknownUpdated: 2026-05-04

Subscription

—unknownUpdated: 2026-05-04

Warranty

—unknownUpdated: 2026-05-04

Return policy (days)

—unknownUpdated: 2026-05-04

Where to buy

Buy at vivistim.comverifiedSource

1. Vivistim — official sitehttps://www.vivistim.com

Updated: 2026-05-04

Media & links

Official site

vivistim.comverifiedSource

1. Vivistim — official sitehttps://www.vivistim.com

Updated: 2026-05-04

Product page

vivistim.comverifiedSource

1. Vivistim — official sitehttps://www.vivistim.com

Updated: 2026-05-04

Editor’s take