K193599 is an FDA 510(k) clearance for the BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair. This device is classified as a Wheelchair, Powered (Class II - Special Controls, product code ITI).
Submitted by 21st Century Scientific, Inc. (Coeur D'Alene, US). The FDA issued a Cleared decision on September 3, 2020, 255 days after receiving the submission on December 23, 2019.
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 | K193599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | September 03, 2020 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| 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). |