K-number	K250053
Device name	TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
Applicant	Shenzhen Jiantuo Electronics Co., Ltd.
Product code	NUH
Device class	Class II
Decision date	May 9, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The TENS AND EMS (JT8012, JT8012B) is a transcutaneous electrical nerve stimulation and electrical muscle stimulation device. TENS is intended for temporary relief of pain from sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities, and lower extremities due to strain from exercise or normal household work. EMS is intended to stimulate healthy muscles to improve and facilitate 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) (JT8012, JT8012B)

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