Name: Predicase
Price: 199 USD

K-number	K231320
Device name	Zhenjiang Assure Mechanical Wheelchair,model:K1
Applicant	Zhenjiang Assure Medical Equipment Co., Ltd.
Product code	IOR
Device class	Class I
Decision date	Jun 5, 2023
Decision	Substantially Equivalent
Regulation	890.3850

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Source

View the full FDA submission: accessdata.fda.gov

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Zhenjiang Assure Mechanical Wheelchair,model:K1

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