510(k) K113525
K113525 is an FDA 510(k) premarket notification submitted by Medical Compression Systems (Dbn) , Ltd. for the device "ACTIVECARE DVT ACTIVECARE+SFT". The FDA issued a decision of Substantially Equivalent on Jan 31, 2012. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Medical Compression Systems (Dbn) , Ltd. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2012
- Date Received
- Nov 29, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type
- 510(k)