Clearance Summary
ABLE-X received FDA 510(k) clearance under submission number K120783, sponsored by Im-Able, 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 2012-06-20.
- Submission: K120783
- Applicant / Sponsor: Im-Able, Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5370
- Decision date: 2012-06-20
Classification & Regulation
This clearance is catalogued under FDA product code ION and 21 CFR 890.5370, within the Physical Medicine review panel as a Class I device.