510(k) K160431
K160431 is an FDA 510(k) premarket notification submitted by Medical Compression Systems (Dbn) , Ltd. for the device "ActiveCare Home". The FDA issued a decision of Substantially Equivalent on Jul 13, 2016. 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
- Jul 13, 2016
- Date Received
- Feb 16, 2016
- 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)