C.T.M. Mobility Scooter, Model HS-628, Invacare Orion
by C.T.M. Homecare Product, Inc. 510(k)
Active
510(k) K091418
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091418 | Date6 Jul 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- INI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The C.T.M. Mobility Scooter, Model Hs-628, Invacare Orion is a Vehicle, Motorized 3-Wheeled device used for transportation. It is classified under the medical specialty of Physical Medicine.
The device is supplied as a single unit and is intended for use by disabled or elderly persons. It has been found to be Substantially Equivalent and has a regulation number of 890.3800. The device has been assigned a product code of INI and has an FDA 510(k) number of K091418.
Other devices from C.T.M. Homecare Product, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the C.T.M. Mobility Scooter HS-628 used for?
The C.T.M. Mobility Scooter, Model HS-628, is used for transportation by disabled or elderly persons, falling under the medical specialty of Physical Medicine.
Is the C.T.M. Mobility Scooter HS-628 supplied as a single unit?
Yes, the C.T.M. Mobility Scooter, Model HS-628, is supplied as a single unit.
What is the regulatory classification of the C.T.M. Mobility Scooter HS-628?
The device has a regulation number of 890.3800 and is classified as a Vehicle, Motorized 3-Wheeled device, with a product code of INI.
What is the FDA 510(k) number for the C.T.M. Mobility Scooter HS-628?
The FDA 510(k) number for the C.T.M. Mobility Scooter, Model HS-628, is K091418.