Name: Predicase
Price: 199 USD

K-number	K220578
Device name	Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Applicant	Bozhou Rongjian Medical Appliance Co., Ltd.
Product code	GZJ
Device class	Class II
Decision date	May 25, 2022
Decision	Substantially Equivalent
Regulation	882.5890

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Source

View the full FDA submission: accessdata.fda.gov

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Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

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