K-number	K243856
Device name	TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
Applicant	Shenzhen Astec Technology Co., Ltd.
Product code	NUH
Device class	Class II
Decision date	May 29, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The TENS and EMS device (five models: AS8012C, AS8016, AS8019, AS9020E, AS9026) is a transcutaneous electrical nerve stimulator for temporary pain relief in sore and aching muscles of the shoulder, waist, back, neck, abdomen, bottom, upper and lower extremities due to strain from exercise or household work. It also functions as an electrical muscle stimulator 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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TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

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