510(k) K182578
K182578 is an FDA 510(k) premarket notification submitted by Devon Medical Products (Jiangsu), Ltd. for the device "Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device". The FDA issued a decision of Substantially Equivalent on Feb 21, 2019. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Devon Medical Products (Jiangsu), Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2019
- Date Received
- Sep 19, 2018
- 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)