510(k) K260944
K260944 is an FDA 510(k) premarket notification submitted by Manamed, LLC for the device "ManaCold Compression System". The FDA issued a decision of Substantially Equivalent on Aug 12, 2026. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Manamed, LLC has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2026
- Date Received
- Mar 23, 2026
- 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)