Pacesaver Eclipse Atlas
by Burke, Inc.
Pacesaver Eclipse Atlas (15073) is an assistive scooter (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Burke, Inc., cleared under FDA 510(k) K965123 on 17 Jul 1997 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI B314150731), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB314150731 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK965123 | Date17 Jul 1997 | StatusActive |
Official records
- FDA 510(k) database K965123
Across registries
- FDA 510(k) K965123 decided 17 Jul 1997 Active
- FDA GUDID UDI-DI B314150731 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K965123
- Listed FDA GUDID B314150731
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pacesaver
- Generic name
- Assistive scooter, electric-motor-driven
- Model / Ref / Catalog
- Eclipse Atlas, 15073
- Primary DI / UDI-DI
- B314150731
- 510(k) Number
- FDA product code
- INI
- GMDN term
- Assistive scooter, electric-motor-driven
- Device class
- Class II
- Regulation number
- 890.3800
- GUDID distribution status
- In Commercial Distribution
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- COYOTE ELECTRIC SCOOTER-3WHEELED by Mobility Mfg. Co.