Arm Cradle 60-560
by Aktina Corp.
Arm Cradle 60-560 is a radiological arm/leg positioner (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Aktina Corp., cleared under FDA 510(k) K991546 on 30 Jul 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B365605600), 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 | NumberB365605600 | Date24 Sep 2016 | 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 B365605600 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K991546
- Listed FDA GUDID B365605600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arm Cradle
- Generic name
- Radiological arm/leg positioner
- Model / reference
- 60-560
- Primary DI / UDI-DI
- B365605600
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiological arm/leg positioner
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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