K-number	K251429
Device name	OTC 4-Channel Rechargeable TENS Unit
Applicant	Changsha Anxiang Medical Technology Co., Ltd.
Product code	NUH
Device class	Class II
Decision date	Aug 28, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The OTC 4-Channel Rechargeable TENS Unit is a transcutaneous electrical nerve stimulation device designed for temporary pain relief in muscles of the shoulder, waist, back, neck, upper and lower extremities, abdomen, and bottom due to strain from exercise or household work. It also includes electrical muscle stimulation (EMS) capability to stimulate healthy muscles and improve muscle performance.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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OTC 4-Channel Rechargeable TENS Unit

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