Activecare ++ System
by Medical Compression Systems (Dbn), Ltd.
510(k) K060146
Activecare ++ System 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) K060146 on 8 Mar 2006, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060146 | Date8 Mar 2006 | StatusActive |
Official records
- FDA 510(k) database K060146
Recalls
-
- Terminated Z-0386-2012
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+S.F.T device might cease to work if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual the ActiveCare+S.
Timeline
- Cleared FDA 510(k) K060146
- Recall initiated FDA recalls Z-0386-2012
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- Withdrawn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
Devices cleared under K060146
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ActiveCare HomeCare ActiveCare+S.F.T | A502B-0002-01 / HomeCare ActiveCare+S.F.T | 17290016525394 | — | On the market |
| ActiveCare+S.F.T | A502B-0001-01 / ActiveCare+S.F.T | 17290016525387 | — | On the market |
Similar devices
Other devices filed under FDA product code JOW (Sleeve, Limb, Compressible).
- RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A by Joy Long
- DVT Motion Pneumatic Compression Device by Koge Micro Tech Co., Ltd.
- Bio Compression Systems Bio Arterial Plus Model IC-BAP-DL-230 by BIO COMPRESSION SYSTEMS, INC.
- KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM by The Kendal Co.
- SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System by Jiangsu Synecoun Medical Technology Co., Ltd.
- JOBST ATHROMBIC PUMP SYSTEM 2600 by Jobst A Beiersdorf Co.
- Therm-X (Home); Therm-X (AT) by Zenith Technical Innovations, LLC.
- Nimbl (model PD08-N1) by Tactile Medical
- ARTERIALFLOW SYSTEM, MODEL 32A by Aircast, Inc.
- REPROCESSED COMPRESSION SLEEVES by Alliance Medical, Inc.
Other devices from Medical Compression Systems (Dbn), Ltd.
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