510(k) K152228
K152228 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare , Ltd. for the device "Hydroven 12, Hydroven 12 Garments". The FDA issued a decision of Substantially Equivalent on April 4, 2016. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Huntleigh Healthcare , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2016
- Date Received
- August 7, 2015
- 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