K211647 is an FDA 510(k) clearance for the HP358EA Electrically Powered Wheelchair. This device is classified as a Wheelchair, Powered (Class II - Special Controls, product code ITI).
Submitted by Kunshan Hi-Fortune Health Products Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on January 4, 2022, 221 days after receiving the submission on May 28, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3860. A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk)..
| 510(k) Number | K211647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2021 |
| Decision Date | January 04, 2022 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ITI - Wheelchair, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3860 |
| Definition | A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk). |