510(k) K230385
K230385 is an FDA 510(k) premarket notification submitted by Mego Afek for the device "Ballancer Platinum (1222)". The FDA issued a decision of Substantially Equivalent on April 4, 2023. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Mego Afek has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2023
- Date Received
- February 14, 2023
- 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