Rascal Power Chair
by Electric Mobility Corp. 510(k)
Active
510(k) K972370
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972370 | Date14 Nov 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0903-06
The four seat mast mounting screws can loosen, causing seat to wobble. The chair seat actuator and portions of the seat can malfunction and/or break. Firm is aware of problems with the seat and injuries sustained from the powered wheelchair/scooter seat malfunction. Firm has not initiated recall, claims it is a Warranty Advisory.
Specification
- 510(k) Number
- FDA Product Code
- ITI
- FDA applicant
- Electric Mobility, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Rascal Power Chair is a powered wheelchair. It is classified as a device under the medical specialty of Physical Medicine.
The Rascal Power Chair is supplied with an FDA 510K authorization. The device is regulated under the regulation number 890.3860 and has a product code of ITI. It is intended for use in the field of physical medicine.