Wizair Dvt
by Medical Compression Systems (Dbn), Ltd.
510(k) K012994
Wizair Dvt is a medical device (FDA Class II; FDA product code JOW, Sleeve, Limb, Compressible) made by Medical Compression Systems (Dbn), Ltd., cleared under FDA 510(k) K012994 on 27 Mar 2002, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012994 | Date27 Mar 2002 | StatusActive |
Official records
- FDA 510(k) database K012994
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOW
- FDA applicant
- Medical Compression Systems (Dbn) , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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