Aria SSK1
Aria SSK1 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K192474 on 10 Oct 2019 and listed in FDA GUDID since 20 Apr 2021 (UDI-DI 00885556803868), 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 | Number00885556803868 | Date20 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192474 | Date10 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 00885556803868
- FDA 510(k) database K192474
Across registries
- FDA 510(k) K192474 decided 10 Oct 2019 Active
- FDA GUDID UDI-DI 00885556803868 listed 20 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K192474
- Listed FDA GUDID 00885556803868
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aria
- Generic name
- Virtual-display rehabilitation system, non-supportive, clinical
- Model / Ref / Catalog
- SSK1
- Primary DI / UDI-DI
- 00885556803868
- 510(k) Number
- FDA product code
- LXJ
- GMDN term
- Virtual-display rehabilitation system, non-supportive, clinical
- Device class
- Class II
- Regulation number
- 890.5360
- GUDID distribution status
- In Commercial Distribution
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