510(k) K193079
K193079 is an FDA 510(k) premarket notification submitted by Mks Paris for the device "ICE COMPRESSION FIRST, DUO, & MOOVE Systems". The FDA issued a decision of Substantially Equivalent on Jan 11, 2021. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2021
- Date Received
- Nov 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)