AnKle Strap Model Lumenair
AnKle Strap Model Lumenair (V23-0006) is an external counterpulsation system (FDA Class II; FDA product code DRN, Device, counter-pulsating, external) made by Vasomedical, Inc., cleared under FDA 510(k) K033617 on 1 Mar 2004 and listed in FDA GUDID since 29 Nov 2016 (UDI-DI 00817980021211), 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 | Number00817980021211 | Date29 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033617 | Date1 Mar 2004 | StatusActive |
Official records
- AccessGUDID record 00817980021211
- FDA 510(k) database K033617
Across registries
- FDA 510(k) K033617 decided 1 Mar 2004 Active
- FDA GUDID UDI-DI 00817980021211 listed 29 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K033617
- Listed FDA GUDID 00817980021211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AnKle Strap
- Generic name
- External counterpulsation system, stationary
- Model / Ref / Catalog
- Model Lumenair, V23-0006
- Primary DI / UDI-DI
- 00817980021211
- 510(k) Number
- FDA product code
- DRN
- GMDN term
- External counterpulsation system, stationary
- Device class
- Class II
- Regulation number
- 870.5225
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code DRN (Device, counter-pulsating, external).
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- ACS MODEL NCP-2 by Applied Cardiac Systems, Inc.
- CARDIASSIST EXTERNAL COUNTERPULSATION by Cardiassist Corp.