Submission Details
| 510(k) Number | K231320 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2023 |
| Decision Date | June 05, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Special
Zhenjiang Assure Mechanical Wheelchair,model:K1
Jun 2023
Decision
28d
Days
Class 1
Risk
About This 510(k) Submission
K231320 is an FDA 510(k) clearance for the Zhenjiang Assure Mechanical Wheelchair,model:K1, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Zhenjiang City, CN). The FDA issued a Cleared decision on June 5, 2023, 28 days after receiving the submission on May 8, 2023. 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. |
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