Clearance Summary
Ballancer 505 System, Model 1201-AC received FDA 510(k) clearance under submission number K150269, 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 2015-05-26.
- Submission: K150269
- 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: 2015-05-26
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.