C.T.M. Mobility Scooter, Model # HS-666
by Warepalmy Enterprise, LLC (Usa)
510(k) K983663
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983663 | Date18 Dec 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 27 Sep 2026
The C.T.M. Mobility Scooter, Model # HS-666 is a motorized three-wheeled vehicle intended for medical purposes and used for transportation by disabled persons. It is classified as a Class II device under regulation number 890.3800.
The device is battery-powered and intended for indoor and outdoor use. It is supplied as a single-use device and is not reusable. The device is not specified as sterile, and no storage conditions are provided in the specifications.
Other devices from Warepalmy Enterprise, LLC (Usa)
Questions
AI-generated answers, 27 Sep 2026
What is the C.T.M. Mobility Scooter, Model # HS-666 used for?
This device is a motorized, three-wheeled vehicle intended for medical purposes. It is designed to provide transportation for disabled persons and is suitable for use both indoors and outdoors.
Is the C.T.M. Mobility Scooter, Model # HS-666 reusable?
No, the device is supplied as a single-use device and is not reusable.
Is the C.T.M. Mobility Scooter, Model # HS-666 sterile?
No, the device is not specified as sterile.
What is the regulatory classification of the C.T.M. Mobility Scooter, Model # HS-666?
The device is classified as a Class II device under regulation number 890.3800.