K052548 is an FDA 510(k) clearance for the UROK ROCKING WHEELCHAIR, MODEL 700-4XX. This device is classified as a Wheelchair, Mechanical (Class I - General Controls, product code IOR).
Submitted by Amg Medical, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on January 6, 2006, 112 days after receiving the submission on September 16, 2005.
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 | K052548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2005 |
| Decision Date | January 06, 2006 |
| Days to Decision | 112 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. |