Name: Predicase
Price: 199 USD

K-number	K213788
Device name	TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
Applicant	Dongguan Bohuikang Technology Co.,Ltd
Product code	NUH
Device class	Class II
Decision date	May 6, 2022
Decision	Substantially Equivalent
Regulation	882.5890

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Source

View the full FDA submission: accessdata.fda.gov

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TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

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