K-number	K250360
Device name	TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
Applicant	Shenzhen Jiantuo Electronics Co., Ltd.
Product code	NUH
Device class	Class II
Decision date	May 11, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is a TENS and EMS device (models JT8012C, JT8016, JT9020E, JT9026) manufactured by Shenzhen Jiantuo Electronics. TENS is used for temporary pain relief in sore and aching muscles across the shoulder, waist, back, neck, abdomen, bottom, upper and lower extremities from strain or normal activities. EMS/PMS stimulates 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. The document confirms substantial equivalence to legally marketed predicate devices or devices that do not require premarket approval application (PMA), but does not provide the specific reasoning, predicate comparisons, or technical arguments supporting this determination.

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) (JT8012C,JT8016,JT9020E,JT9026)

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