K160031 is an FDA 510(k) clearance for the Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC). This device is classified as a Wheelchair, Powered (Class II - Special Controls, product code ITI).
Submitted by Sunrise Medical (Us), LLC (Fresno, US). The FDA issued a Cleared decision on July 14, 2016, 189 days after receiving the submission on January 7, 2016.
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 | K160031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2016 |
| Decision Date | July 14, 2016 |
| Days to Decision | 189 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). |