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discount TENS DT-PROBE-V-3

by Everyway Medical Instruments Co., Ltd.

discount TENS DT-PROBE-V-3 is a Class II device made by Everyway Medical Instruments Co., Ltd., cleared under FDA 510(k) K213116 on 3 Dec 2021 and listed in FDA GUDID since 2 Sep 2026 (UDI-DI 04719871186053), 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) K213116

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 Number04719871186053 UDI-DI Date2 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213116 Date3 Dec 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213116 decided 3 Dec 2021 Active
  • FDA GUDID UDI-DI 04719871186053 listed 2 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213116
  2. Listed FDA GUDID 04719871186053

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
discount TENS
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
DT-PROBE-V-3
Primary DI / UDI-DI
04719871186053
510(k) Number
FDA product code
KPI
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
876.5320
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K213116)

and 8 more cleared under K213116

Other devices from Everyway Medical Instruments Co., Ltd.

See all devices from Everyway Medical Instruments Co., Ltd. →

Properties

  • Over-the-counter
Other properties (14, all answered No)