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Cathay CM50100FB

by Cathay Manufacturing Corp.

Cathay CM50100FB is a Class II device made by Cathay Manufacturing Corp., cleared under FDA 510(k) K020735 on 12 Jul 2002 and listed in FDA GUDID since 12 Apr 2017 (UDI-DI 06959006302646), 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) K020735

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 Number06959006302646 UDI-DI Date12 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020735 Date12 Jul 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020735 decided 12 Jul 2002 Active
  • FDA GUDID UDI-DI 06959006302646 listed 12 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020735
  2. Listed FDA GUDID 06959006302646

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cathay
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / reference
CM50100FB
Primary DI / UDI-DI
06959006302646
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 (K020735)

and 4 more cleared under K020735

Similar devices

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

Other devices from Cathay Manfacturing Corp.

See all devices from Cathay Manfacturing Corp. →

Properties

  • Prescription use
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)