Transcutaneous Electrical Nerve Stimulator

FDA 510(k) K210223 · Top-Rank Health Care Co., Ltd.

Substantially Equivalent

510(k) numberK210223

Submission

Device name
Transcutaneous Electrical Nerve Stimulator
Applicant
Top-Rank Health Care Co., Ltd.
Shaoxing, CN
Received
January 28, 2021
Decision date
December 15, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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Questions and answers

When was Transcutaneous Electrical Nerve Stimulator cleared by the FDA?

Transcutaneous Electrical Nerve Stimulator (K210223) received a 510(k) decision of Substantially Equivalent on December 15, 2021, 321 days after the submission was received.

What is the product code of K210223?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.