Name: Predicase
Price: 199 USD

K-number	K181207
Device name	Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
Applicant	Everyway Medical Instruments Co., Ldt.
Product code	NUH
Device class	Class II
Decision date	Jun 6, 2018
Decision	Substantially Equivalent
Regulation	882.5890

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Source

View the full FDA submission: accessdata.fda.gov

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Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

Everything you need for a 510(k) submission. Nothing you don't.