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Baxter-022

by Pro Medical Supplies, Inc. 3 variants

Baxter-022 is a Class II device made by Pro Medical Supplies, Inc., cleared under FDA 510(k) K132998 on 20 Dec 2013 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 20185098000843), active as of 23 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 23 Oct 2026

Documents

510(k) K132998

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20185098000843 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK132998 Date20 Dec 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132998 decided 20 Dec 2013 Active
  • FDA GUDID UDI-DI 20185098000843 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132998
  2. Listed FDA GUDID 20185098000843

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Baxter
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / Ref / Catalog
Baxter-022
Primary DI / UDI-DI
20185098000843
510(k) Number
FDA product code
GXY
GMDN term
Transcutaneous electrical stimulation electrode, single-use
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcutaneous electrical stimulation electrode, single-use

Cleared under the same submission (K132998)

and 8 more cleared under K132998

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Pro Medical Supplies, Inc.

See all devices from Pro Medical Supplies, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)