K140416 is an FDA 510(k) clearance for the TREKKER, TREKKER TRANSIT. This device is classified as a Wheelchair, Mechanical (Class I - General Controls, product code IOR).
Submitted by Convaid Products, Inc. (Torrance, US). The FDA issued a Cleared decision on September 17, 2014, 211 days after receiving the submission on February 18, 2014.
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 | K140416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | September 17, 2014 |
| Days to Decision | 211 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. |