Clearance Summary
MODIFICATION TO RELIEF BRIEF received FDA 510(k) clearance under submission number K003128, sponsored by The JM Kohn Co.. 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 2002-08-12.
- Submission: K003128
- Applicant / Sponsor: The JM Kohn Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3490
- Decision date: 2002-08-12
Classification & Regulation
This clearance is catalogued under FDA product code NJB and 21 CFR 890.3490, within the Physical Medicine review panel as a Class I device.