K-number	K253305
Device name	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
Applicant	Shenzhen Jiantuo Electronics Co., Ltd.
Product code	NUH
Device class	Class II
Decision date	Dec 31, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This device is a TENS and EMS (Electrical Muscle Stimulation) unit with four models (JT1065, JT1080, JT2080, JT9034). TENS is used for temporary relief of pain in muscles of the shoulder, waist, back, abdomen, bottom, upper and lower extremities due to strain from exercise or household activities. EMS is used to stimulate healthy muscles to improve and facilitate muscle performance. It is marketed as an over-the-counter device.

Technological characteristics

Not stated in this summary.

Test standards cited

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) (JT1065, JT1080, JT2080, JT9034)

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