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TensCare Form Duo

by Tenscare Limited

TensCare Form Duo is a medical device (FDA Class II) made by Tenscare Limited, cleared under FDA 510(k) K200694 on 4 Jun 2021 and listed in FDA GUDID since 25 Jul 2024 (UDI-DI 05033435136933), 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) K200694

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 Number05033435136933 UDI-DI Date25 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK200694 Date4 Jun 2021IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200694 decided 4 Jun 2021 Active
  • FDA GUDID UDI-DI 05033435136933 listed 25 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200694
  2. Listed FDA GUDID 05033435136933

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TensCare
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
Form Duo
Primary DI / UDI-DI
05033435136933
510(k) Number
FDA product code
NUH, NGX
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
882.5890, 890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Cleared under the same submission (K200694)

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Other devices from Tenscare Limited

See all devices from Tenscare Limited →

Properties

  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)