SUNRISE SCOOTER SERIES - 4 Whe
510(k) K981885
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981885 | Date12 Nov 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- Withdrawn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
- Models / Variants
- 4 Whe
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Sunrise Scoer Series is a motorized 3-wheeled vehicle designed for mobility assistance. It is available in multiple models including standard, mid-range, and high-end configurations, as well as a 4-wheel option. These scooters are classified under physical medicine and are intended to provide mobility support for users.
The Sunrise Scoer Series is supplied as a non-sterile, reusable device. It is FDA 510(k) cleared with product code INI and is manufactured by Sunrise Medical, Inc. The device is stored at room temperature and is available in various sizes as specified by the manufacturer. No specific MRI safety information is provided in the device data.
Other devices from Sunrise Medical
Questions
AI-generated answers, 23 Sep 2026
What is the Sunrise Scooter Series designed for?
The Sunrise Scooter Series is a motorized 3-wheeled vehicle designed for mobility assistance, available in standard, mid-range, and high-end configurations, as well as a 4-wheel option to provide mobility support for users.
How is the Sunrise Scooter Series supplied and is it reusable?
The Sunrise Scooter Series is supplied as a non-sterile, reusable device that is stored at room temperature. It is designed for long-term use rather than single-use applications.
What regulatory status does the Sunrise Scooter Series have?
The Sunrise Scooter Series is FDA 510(k) cleared with product code INI and is classified under physical medicine, indicating it has been determined substantially equivalent to other legally marketed devices.
Are there different models available in the Sunrise Scooter Series?
Yes, the Sunrise Scooter Series is available in multiple models including standard, mid-range, and high-end 3-wheel configurations, as well as a 4-wheel option to accommodate different user requirements and preferences.