510(k) K192252
K192252 is an FDA 510(k) premarket notification submitted by Menlo Brands, LLC for the device "ProPerformance Recovery System". The FDA issued a decision of Substantially Equivalent on Sep 19, 2019. 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
- Sep 19, 2019
- Date Received
- Aug 20, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)