Cleared Traditional

Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) (K242567) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242567 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine device
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Nov 2024
Decision
67d
Days
Class 2
Risk

K242567 is an FDA 510(k) clearance for the Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator .... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Changsha Anxiang Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on November 4, 2024 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Changsha Anxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K242567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K242567.
POCKET TENS (EP-300)
K242815 · Hivox Biotek, Inc. · Dec 2024
Nooro Body & Foot Stimulator (SM9141, SM9142)
K243334 · Xf Agencija Limited · Nov 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
K242332 · Shenzhen Kentro Medical Electronics Co., Ltd. · Nov 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · Well-Life Healthcare Limited · Oct 2024
TENS & EMS Stimulator (MHD-1083)
K241678 · Shenzhen Minghuangda Electronics Co., Ltd. · Sep 2024
Pixie Pulse (SM9068)
K241365 · Pixie Cup, LLC · Aug 2024