K032731 is an FDA 510(k) clearance for the MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS. This device is classified as a Wheelchair, Mechanical (Class I - General Controls, product code IOR).
Submitted by Turbo Wheelchair Co., Inc. (Beaufort, US). The FDA issued a Cleared decision on October 30, 2003, 57 days after receiving the submission on September 3, 2003.
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 | K032731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2003 |
| Decision Date | October 30, 2003 |
| Days to Decision | 57 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| 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. |