ShoulderAssist, PositionPro 50-830
by Aktina Corp.
ShoulderAssist, PositionPro 50-830 is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Aktina Corp., cleared under FDA 510(k) K103616 on 25 Jan 2011 and listed in FDA GUDID since 5 Jan 2021 (UDI-DI B365508300), 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 | NumberB365508300 | Date5 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103616 | Date25 Jan 2011 | StatusActive |
Official records
- FDA 510(k) database K103616
Across registries
- FDA 510(k) K103616 decided 25 Jan 2011 Active
- FDA GUDID UDI-DI B365508300 listed 5 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K103616
- Listed FDA GUDID B365508300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ShoulderAssist, PositionPro
- Generic name
- Stereotactic radiosurgical/radiotherapy arch head frame
- Model / reference
- 50-830
- Primary DI / UDI-DI
- B365508300
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Stereotactic radiosurgical/radiotherapy arch head frame
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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