Name: Predicase
Price: 199 USD

K-number	K190009
Device name	Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Applicant	Hong Qiangxing (Shenzhen) Electronics Limited
Product code	NUH
Device class	Class II
Decision date	Dec 2, 2019
Decision	Substantially Equivalent
Regulation	882.5890

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Source

View the full FDA submission: accessdata.fda.gov

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Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

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