Clearance Summary
CARE ETS received FDA 510(k) clearance under submission number K023036, sponsored by Care Rehab and Orthopaedic. 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 2003-06-19.
- Submission: K023036
- Applicant / Sponsor: Care Rehab and Orthopaedic
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2003-06-19
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.