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Revitive ProHealth 5572AQ

by Actegy, Ltd.

Revitive ProHealth 5572AQ (6302) is a Class II device made by Actegy, Ltd., cleared under FDA 510(k) K192887 on 4 May 2020 (2 earlier submissions) and listed in FDA GUDID since 21 Jan 2021 (UDI-DI 00858058005252), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858058005252 UDI-DI Date21 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192887 Date4 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192887 decided 4 May 2020 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00858058005252 listed 21 Jan 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K152480
  2. Cleared FDA 510(k) K190924
  3. Cleared FDA 510(k) K192887
  4. Listed FDA GUDID 00858058005252

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Revitive ProHealth
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Ref / Catalog
5572AQ, 6302
Primary DI / UDI-DI
00858058005252
FDA product code
NGX, IPF
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Actegy, Ltd.

See all devices from Actegy, Ltd. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)