K-number	K171802
Device name	ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Applicant	Bayer Healthcare, LLC
Product code	NUH
Device class	Class II
Decision date	Mar 7, 2018
Decision	Substantially Equivalent
Regulation	882.5890

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Source

View the full FDA submission: accessdata.fda.gov

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ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

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