Adjustable Knee Support 60-543
by Aktina Corp.
Adjustable Knee Support 60-543 is an indexed-immobilization patient positioning system (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Aktina Corp., cleared under FDA 510(k) K103616 on 25 Jan 2011 (1 earlier submission) and listed in FDA GUDID since 21 May 2021 (UDI-DI B365605430), 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 | NumberB365605430 | Date21 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103616 | Date25 Jan 2011 | StatusActive |
Official records
- FDA 510(k) database K103616
- FDA 510(k) database K991546
Across registries
- FDA 510(k) K103616 decided 25 Jan 2011 Active
- FDA GUDID UDI-DI B365605430 listed 21 May 2021 Listed
Timeline
- Cleared FDA 510(k) K991546
- Cleared FDA 510(k) K103616
- Listed FDA GUDID B365605430
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Adjustable Knee Support
- Generic name
- Indexed-immobilization patient positioning system
- Model / reference
- 60-543
- Primary DI / UDI-DI
- B365605430
- FDA product code
- IYE
- GMDN term
- Indexed-immobilization patient positioning system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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