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Tens Maker We-201

by Hivox Biotek Inc.

Tens Maker We-201 is a medical device (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Hivox Biotek Inc., cleared under FDA 510(k) K141921 on 16 Jan 2015 and listed in FDA GUDID since 22 Mar 2022 (UDI-DI 04719880810123), 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) K141921

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 Number04719880810123 UDI-DI Date22 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141921 Date16 Jan 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141921 decided 16 Jan 2015 Active
  • FDA GUDID UDI-DI 04719880810123 listed 22 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141921
  2. Listed FDA GUDID 04719880810123

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tens Maker
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
WE-201
Primary DI / UDI-DI
04719880810123
510(k) Number
FDA product code
NGX
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Hivox Biotek Inc.

See all devices from Hivox Biotek Inc. →

Properties

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