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Innovo 208

by Atlantic Therapeutics, Ltd. 35 variants

Innovo 208 (0209-5006) is a Class II device made by Atlantic Therapeutics, Ltd., cleared under FDA 510(k) K192357 on 16 Jan 2020, granted FDA De Novo DEN170049 on 6 Nov 2018 and listed in FDA GUDID since 11 May 2021 (UDI-DI 15391533471156), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k) De Novo

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15391533471156 UDI-DI Date11 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192357 Date16 Jan 2020DecidedStatusActive
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN170049 Date6 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K192357 decided 16 Jan 2020 Active
  • FDA De Novo DEN170049 decided 6 Nov 2018 Active
  • FDA GUDID UDI-DI 15391533471156 listed 11 May 2021 Listed

Timeline

3 dated events

  1. Granted FDA De Novo DEN170049
  2. Cleared FDA 510(k) K192357
  3. Listed FDA GUDID 15391533471156

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo, FDA 510(k) Active

Specification

GUDID

Trade name
Innovo
Generic name
Electrode conductive medium
Model / Ref / Catalog
208, 0209-5006
Primary DI / UDI-DI
15391533471156
510(k) Number
De Novo Number
FDA product code
QAJ
GMDN term
Electrode conductive medium
Device class
Class II
Regulation number
876.5330
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemElectrode conductive medium

Cleared under the same submission (DEN170049)

and 8 more cleared under DEN170049

Cleared under the same submission (K192357)

and 8 more cleared under K192357

Other devices from Atlantic Therapeutics, Ltd.

  • Innovo 208

    Class II

  • Innovo 208

    Class II

  • Innovo 208

    Class II

  • Innovo 208

    Class II

See all devices from Atlantic Therapeutics, Ltd. →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)