K-number	K251706
Device name	TENS and EMS Unit
Applicant	Changsha Anxiang Medical Technology Co., Ltd.
Product code	NGX
Device class	Class II
Decision date	Jul 30, 2025
Decision	Substantially Equivalent
Regulation	890.5850

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The TENS and EMS Unit is a powered muscle stimulator designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities, 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.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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TENS and EMS Unit

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