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Caring Mill EM44CM Replacement Pads

by Caring Mill

Caring Mill EM44CM Replacement Pads (664.71) is a Class II device made by Caring Mill, cleared under FDA 510(k) K132998 on 20 Dec 2013 and listed in FDA GUDID since 25 Jan 2021 (UDI-DI 00810025923419), 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) K132998

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 Number00810025923419 UDI-DI Date25 Jan 2021ListedStatusListed 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 00810025923419 listed 25 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132998
  2. Listed FDA GUDID 00810025923419

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Caring Mill
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / Ref / Catalog
EM44CM Replacement Pads, 664.71
Primary DI / UDI-DI
00810025923419
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

Similar devices

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

Other devices from Caring Mill

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Properties

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