Cleared Traditional

Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)

K242567 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

Nov 2024

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K242567 is an FDA 510(k) clearance for the Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Changsha Anxiang Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on November 4, 2024, 67 days after receiving the submission on August 29, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K242567 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2024
Decision Date	November 04, 2024
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles