Cleared Traditional

Manual Wheelchair (HM305-Air1, HM305-Air2)

K252687 · Suzhou Master Machinery Manufacturing Co.,Ltd · Physical Medicine

Nov 2025

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K252687 is an FDA 510(k) clearance for the Manual Wheelchair (HM305-Air1, HM305-Air2), a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan, CN). The FDA issued a Cleared decision on November 21, 2025, 87 days after receiving the submission on August 26, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K252687 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2025
Decision Date	November 21, 2025
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — General Controls
CFR Regulation	21 CFR 890.3850
Definition	A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets ?mobility To Persons Restricted To A Sitting Position? To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.