510(k) K242754
K242754 is an FDA 510(k) premarket notification submitted by Zamar Medical D.O.O. for the device "ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)". The FDA issued a decision of Substantially Equivalent on May 5, 2025. 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
- May 5, 2025
- Date Received
- September 12, 2024
- 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