SmartVest SV-CORD-US
SmartVest SV-CORD-US is a Class II device made by Electromed, Inc., cleared under FDA 510(k) K053248 on 1 Dec 2005 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI B102070716S0100), 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 | NumberB102070716S0100 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053248 | Date1 Dec 2005 | StatusActive |
Official records
- FDA 510(k) database K053248
Across registries
- FDA 510(k) K053248 decided 1 Dec 2005 Active
- FDA GUDID UDI-DI B102070716S0100 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K053248
- Listed FDA GUDID B102070716S0100
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- Withdrawn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
- SV-CORD-US
- Description
- Power Cord – North America
- Primary DI / UDI-DI
- B102070716S0100
- 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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