Clearance Summary
AIR MASSAGE SYSTEM received FDA 510(k) clearance under submission number K780710, sponsored by Theracom C/O Arent, Fox, Kintner, Plotki. 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 1978-05-09.
- Submission: K780710
- Applicant / Sponsor: Theracom C/O Arent, Fox, Kintner, Plotki
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 1978-05-09
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.