Activecare Dvt Activecare+sft

510(k) Number

K113525 ↗

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

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices filed under FDA product code JOW (Sleeve, Limb, Compressible).

• Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System by Devon Medical Products (Jiangsu), Ltd.
• SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) by Sentech Medical Systems, Inc.
• entré Model PD08-U by TACTILE SYSTEMS TECHNOLOGY INC
• WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N by WMI ENTERPRISES, LLC
• REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES by Covidien llc
• CIRONA DVT FOOT GARMENT by Devon Medical, Inc.
• RESTEP DVY SYSTEM, MODEL RSP-101 by Stortford Medical, LLC
• Calf&Thigh M NRC-DVT DVT C&T M SPU L4ZD2420 by MEGO afek Agricultural Cooperative Society Ltd
• PlasmaFlow X Compression Sleeve Device (XPF0001) by MANAMED LLC
• CIRCUL8 Luxe DVT Prevention Device by Ortho8, Inc.

• Activecare ++ System

  Class II

  FDA 510(k) K060146 Active Cleared 8 Mar 2006

• Slendair 4000 Compression System

  Class II

  FDA 510(k) K994057 Active Cleared 3 Mar 2000

• Wizair Dvt

  Class II

  FDA 510(k) K012994 Active Cleared 27 Mar 2002

• Activecare DVT, Activecare+SFT, and Activecare+DTX Systems

  Class II

  FDA 510(k) K140755 Active Cleared 8 May 2014

See all devices from Medical Compression Systems (Dbn), Ltd. →