510(k) K190015
K190015 is an FDA 510(k) premarket notification submitted by Mego Afek AC , Ltd. for the device "Ballancer Gold, 1212". The FDA issued a decision of Substantially Equivalent on Mar 25, 2019. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Mego Afek AC , Ltd. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 2019
- Date Received
- Jan 3, 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)