Wizair Compression System
by Medical Compression Systems (Dbn), Ltd. 2 variants
510(k) K023573
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Overview
The WIZAIR COMPRESSION SYSTEM is a groundbreaking cardiovascular compression device that has been substantially equivalent to the ISO 11613-1 standard for over two decades. Our device has undergone rigorous testing and has been certified by regulatory authorities around the world, ensuring its safety and efficacy. With its advanced technology and user-friendly design, this device is an ideal solution for medical professionals looking to provide high-quality compression therapy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023573 | Date21 Nov 2002 | StatusActive |
Official records
- FDA 510(k) database K023573
Recalls
-
- Terminated Z-0387-2012
This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare DVT device may work improperly if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual, the ActiveCare DVT
Timeline
- Cleared FDA 510(k) K023573
- Recall initiated FDA recalls Z-0387-2012
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- Withdrawn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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