3 in 1 TENS UNIT - TS1241

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251187

by Changsha Anxiang Medical Technology Co., LTD

Identifiers

510(k) Number: K251187 FDA 510(k)
FDA Product Code: NUH FDA 510(k)
Models / Variants: TC1241 FDA 510(k)
TC2241 FDA 510(k)
TS1241 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.5890 FDA 510(k)
Regulation Number: 882.5890 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The 3 In 1 Tens Unit (TC1241, TC2241, TS1241) is a stimulator, nerve, device. It is a type of medical device used for nerve stimulation. The device is manufactured by Changsha Anxiang Medical Technology Co., Ltd.

The device is supplied with the model numbers TC1241, TC2241, and TS1241. It has a product code of NUH and is classified under the regulation 882.5890. The device received FDA 510K clearance on July 28, 2025.

Frequently asked questions

What is the 3 in 1 TENS UNIT used for?

The 3 in 1 TENS UNIT is used for nerve stimulation, providing relief through electrical impulses.

What models are available for the 3 in 1 TENS UNIT?

The 3 in 1 TENS UNIT is available in models TC1241, TC2241, and TS1241.

Is the 3 in 1 TENS UNIT cleared by the FDA?

Yes, the 3 in 1 TENS UNIT received FDA 510K clearance on July 28, 2025, indicating it is substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (K251187) — FDA 510(k ..., TENS Unit (K251187) | Medical Device Navigator, 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) — FDA K251187, 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) 510(k) K251187 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K251187	Class II	Active

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Manufacturer

Manufacturer: Changsha Anxiang Medical Technology Co., LTD
FDA Applicant: Changsha Anxiang Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K251187 24 fields · synced Sep 21, 2026