Name: Predicase
Price: 199 USD

K-number	K211937
Device name	SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Applicant	Jiangsu Synecoun Medical Technology Co., Ltd.
Product code	JOW
Device class	Class II
Decision date	Nov 18, 2021
Decision	Substantially Equivalent
Regulation	870.5800

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Source

View the full FDA submission: accessdata.fda.gov

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SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

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