Clearance Summary
MOTIVATOR FTR 2000 received FDA 510(k) clearance under submission number K942229, sponsored by Hogan & Hartson. 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 1995-02-27.
- Submission: K942229
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1925
- Decision date: 1995-02-27
Classification & Regulation
This clearance is catalogued under FDA product code IKK and 21 CFR 890.1925, within the Physical Medicine review panel as a Class II device.