Submission Details
| 510(k) Number | K112816 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2011 |
| Decision Date | April 18, 2012 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
ZHENJIANG ASURE MECHANICAL WHEELCHAIR
Apr 2012
Decision
203d
Days
Class 1
Risk
About This 510(k) Submission
K112816 is an FDA 510(k) clearance for the ZHENJIANG ASURE MECHANICAL WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on April 18, 2012, 203 days after receiving the submission on September 28, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.
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. |
Manufacturer
Similar Devices — IOR Wheelchair, Mechanical
All 452
K253632 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
· Jan 2026
K251886 · Empower Ride, LLC
· Jan 2026
K252825 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
· Dec 2025
K252828 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
· Dec 2025
K252687 · Suzhou Master Machinery Manufacturing Co.,Ltd
· Nov 2025
K250576 · Karma Mobility Co, Ltd.
· Nov 2025
More from Zhenjiang Assure Medical...
View all
K251159
· ITI · Dec 2025
K232230
· IOR · Oct 2023
K232198
· IOR · Sep 2023
K232199
· IOR · Sep 2023
K231320
· IOR · Jun 2023