K241159 is an FDA 510(k) clearance for the Handbike Batec Electric. This device is classified as a Wheelchair, Powered (Class II - Special Controls, product code ITI).
Submitted by Batec Mobility, S.L. (Sant Quirze Del Vallès, ES). The FDA issued a Cleared decision on March 7, 2025, 315 days after receiving the submission on April 26, 2024.
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 | K241159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2024 |
| Decision Date | March 07, 2025 |
| Days to Decision | 315 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). |