K163352 is an FDA 510(k) clearance for the Wheelchair. This device is classified as a Wheelchair, Mechanical (Class I - General Controls, product code IOR).
Submitted by Kunshan Hi-Fortune Health Products Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on July 28, 2017, 240 days after receiving the submission on November 30, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850. 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..
| 510(k) Number | K163352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2016 |
| Decision Date | July 28, 2017 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| 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. |