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Caring Mill ACNCMTENSSP

by Caring Mill

Caring Mill ACNCMTENSSP is a Class II device made by Caring Mill, cleared under FDA 510(k) K171381 on 13 Dec 2017 and listed in FDA GUDID since 19 Mar 2021 (UDI-DI 00810025923839), 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) K171381

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 Number00810025923839 UDI-DI Date19 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171381 Date13 Dec 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171381 decided 13 Dec 2017 Active
  • FDA GUDID UDI-DI 00810025923839 listed 19 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171381
  2. Listed FDA GUDID 00810025923839

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  • Withdrawn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, reusable
Model / Ref / Catalog
ACNCMTENSSP
Primary DI / UDI-DI
00810025923839
510(k) Number
FDA product code
GXY
GMDN term
Transcutaneous electrical stimulation electrode, reusable
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)