K-number	K242787
Device name	Tens & Ems Device (TU1080)
Applicant	Changsha Anxiang Medical Technology Co., Ltd.
Product code	NGX
Device class	Class II
Decision date	Dec 18, 2024
Decision	Substantially Equivalent
Regulation	890.5850

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Tens & Ems Device (TU1080) is a combination transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulator (EMS) device. It is designed for temporary relief of pain from sore and aching muscles in various body locations due to strain from exercise or household activities (TENS mode), and to stimulate healthy muscles to improve muscle performance (EMS mode). The device is for over-the-counter use.

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 & Ems Device (TU1080)

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