Clearance Summary
MAGNATHERM MODEL 1000 SS received FDA 510(k) clearance under submission number K934151, sponsored by Intl. Medical Electronics , 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 1995-02-17.
- Submission: K934151
- Applicant / Sponsor: Intl. Medical Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5290
- Decision date: 1995-02-17
Classification & Regulation
This clearance is catalogued under FDA product code IMJ and 21 CFR 890.5290, within the Physical Medicine review panel as a Class II device.