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ActiPatch 077

by Bioelectronics Corporation

ActiPatch 077 (168) is a Class II device made by Bioelectronics Corporation, cleared under FDA 510(k) K152432 on 3 Feb 2017 and listed in FDA GUDID since 23 Jul 2020 (UDI-DI 00851329005203), 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

510(k) K152432

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851329005203 UDI-DI Date23 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152432 Date3 Feb 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152432 decided 3 Feb 2017 Active
  • FDA GUDID UDI-DI 00851329005203 listed 23 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152432
  2. Listed FDA GUDID 00851329005203

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ActiPatch
Generic name
Hand-held deep-tissue electromagnetic stimulator
Model / Ref / Catalog
077, 168
Description
Back , Knee, Muscle and Joint 7 day trial
Primary DI / UDI-DI
00851329005203
FDA product code
PQY
GMDN term
Hand-held deep-tissue electromagnetic stimulator
Device class
Class II
Regulation number
890.5290
GUDID distribution status
In Commercial Distribution

Other devices from Bioelectronics Corporation

See all devices from Bioelectronics Corporation →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)