Skip to content

Avcoo EB2M20

by Adp Health Limited 2 variants

Avcoo EB2M20 (EB2M20C21) is a Class II device made by Adp Health Limited, cleared under FDA 510(k) K160138 on 11 Aug 2016 and listed in FDA GUDID since 18 Sep 2025 (UDI-DI 00850073128176), 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) K160138

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 Number00850073128176 UDI-DI Date18 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160138 Date11 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160138 decided 11 Aug 2016 Active
  • FDA GUDID UDI-DI 00850073128176 listed 18 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160138
  2. Listed FDA GUDID 00850073128176

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Avcoo
Generic name
Interferential electrical stimulation system electrode
Model / Ref / Catalog
EB2M20, EB2M20C21
Primary DI / UDI-DI
00850073128176
510(k) Number
FDA product code
GXY
GMDN term
Interferential electrical stimulation system electrode
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Other devices from Adp Health Limited

See all devices from Adp Health Limited →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)