K111278 is an FDA 510(k) clearance for the Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE. This device is classified as a Wheelchair, Powered (Class II — Special Controls, product code ITI).
Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on September 16, 2011, 134 days after receiving the submission on May 5, 2011.
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 | K111278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2011 |
| Decision Date | September 16, 2011 |
| Days to Decision | 134 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). |