Name: Predicase
Price: 199 USD

K-number	K252687
Device name	Manual Wheelchair (HM305-Air1, HM305-Air2)
Applicant	Suzhou Master Machinery Manufacturing Co.,Ltd
Product code	IOR
Device class	Class I
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	890.3850

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Manual Wheelchair (HM305-Air1, HM305-Air2)

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