K-number	K243511
Device name	OTC TENS & EMS Unit
Applicant	Changsha Anxiang Medical Technology Co., Ltd.
Product code	NGX
Device class	Class II
Decision date	Feb 10, 2025
Decision	Substantially Equivalent
Regulation	890.5850

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The OTC TENS & EMS Unit is a transcutaneous electrical nerve stimulation and electrical muscle stimulation device designed to temporarily relieve muscle soreness and pain in various body areas (shoulder, waist, back, neck, upper/lower extremities, abdomen, and bottom) caused by exercise or household activities. It is also used to stimulate healthy muscles to 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. The document confirms the device is substantially equivalent to legally marketed predicate devices but does not provide the specific reasoning, technological comparisons, or predicates upon which this determination was based. The enclosure referenced in the letter would contain this detailed information.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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OTC TENS & EMS Unit

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