Clearance Summary
ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT received FDA 510(k) clearance under submission number K060191, sponsored by Accelerated Care Plus Corp.. 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 2006-07-12.
- Submission: K060191
- Applicant / Sponsor: Accelerated Care Plus Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2006-07-12
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.