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ZIDA Wearable Neuromodulation System

by Exodus Innovations 510(k)

Active United States

510(k) K192731

Overview

The ZIDA Wearable Neuromodulation System is a peripheral nerve stimulator designed for non-implanted use. It is intended for the management of urinary incontinence and is classified as a Class 2 medical device under FDA regulation.

The device is supplied as a single-use, non-sterile unit and is not MRI safe. It should be stored in a dry environment and is cleared under FDA 510(k) K192731 for traditional review.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192731 Date19 Mar 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NAM
Device Class
Class II
Regulation
21 CFR Part 876.5310
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the ZIDA Wearable Neuromodulation System used for?

    The ZIDA Wearable Neuromodulation System is a peripheral nerve stimulator designed for non-implanted use, specifically intended for the management of urinary incontinence. It is classified as a Class 2 medical device under FDA regulation.

  • How is the ZIDA device supplied and what are its sterility requirements?

    The ZIDA Wearable Neuromodulation System is supplied as a single-use, non-sterile unit. It is not MRI safe and should be stored in a dry environment to maintain its functionality and safety.

  • What is the regulatory status of the ZIDA Wearable Neuromodulation System?

    The ZIDA Wearable Neuromodulation System is cleared under FDA 510(k) K192731 for traditional review, with a decision code of SESE (Substantially Equivalent). It was reviewed by the Gastroenterology, Urology advisory committee.

  • Is the ZIDA device reusable or single-use only?

    The ZIDA Wearable Neuromodulation System is designed as a single-use device only. After use, it should not be reused or repurposed for any other patient or application.