swiftPro Battery Pack SWF-BAT01
swiftPro Battery Pack SWF-BAT01 is a secondary battery (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Emblation Limited, cleared under FDA 510(k) K240518 on 23 Apr 2024 and listed in FDA GUDID since 26 Jun 2024 (UDI-DI 05060652910138), 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 | Number05060652910138 | Date26 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240518 | Date23 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 05060652910138
- FDA 510(k) database K240518
Across registries
- FDA 510(k) K240518 decided 23 Apr 2024 Active
- FDA GUDID UDI-DI 05060652910138 listed 26 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K240518
- Listed FDA GUDID 05060652910138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- swiftPro Battery Pack
- Generic name
- Secondary battery
- Model / Ref / Catalog
- SWF-BAT01
- Primary DI / UDI-DI
- 05060652910138
- FDA product code
- NEY
- GMDN term
- Secondary battery
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Secondary battery.