SmartVest SQL_R
SmartVest SQL_R is a Class II device made by Electromed, Inc., cleared under FDA 510(k) K132794 on 19 Dec 2013 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI B102090488S0110), 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 | NumberB102090488S0110 | Date30 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132794 | Date19 Dec 2013 | StatusActive |
Official records
- FDA 510(k) database K132794
Across registries
- FDA 510(k) K132794 decided 19 Dec 2013 Active
- FDA GUDID UDI-DI B102090488S0110 listed 30 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K132794
- Listed FDA GUDID B102090488S0110
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SmartVest
- Generic name
- Chest-oscillation airway secretion-clearing system vest
- Model / Ref / Catalog
- SQL_R
- Primary DI / UDI-DI
- B102090488S0110
- 510(k) Number
- FDA product code
- BYI
- GMDN term
- Chest-oscillation airway secretion-clearing system vest
- Device class
- Class II
- Regulation number
- 868.5665
- GUDID distribution status
- In Commercial Distribution
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