Clearance Summary
Ballancer Gold, 1212 received FDA 510(k) clearance under submission number K190015, sponsored by Mego Afek AC , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2019-03-25.
- Submission: K190015
- Applicant / Sponsor: Mego Afek AC , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2019-03-25
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.