Arm Positioning Kit 11-230
by Aktina Corp.
Arm Positioning Kit 11-230 is an indexed-immobilization patient positioning system (FDA Class II; FDA product code JAI, Couch, Radiation Therapy, Powered) made by Aktina Corp., cleared under FDA 510(k) K991546 on 30 Jul 1999 and listed in FDA GUDID since 21 May 2021 (UDI-DI B365112300), 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 | NumberB365112300 | Date21 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991546 | Date30 Jul 1999 | StatusActive |
Official records
- FDA 510(k) database K991546
Across registries
- FDA 510(k) K991546 decided 30 Jul 1999 Active
- FDA GUDID UDI-DI B365112300 listed 21 May 2021 Listed
Timeline
- Cleared FDA 510(k) K991546
- Listed FDA GUDID B365112300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arm Positioning Kit
- Generic name
- Indexed-immobilization patient positioning system
- Model / reference
- 11-230
- Primary DI / UDI-DI
- B365112300
- 510(k) Number
- FDA product code
- JAI
- GMDN term
- Indexed-immobilization patient positioning system
- Device class
- Class II
- Regulation number
- 892.5770
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Indexed-immobilization patient positioning system.