Clearance Summary
P.T. MACHINE received FDA 510(k) clearance under submission number K974626, sponsored by Goodman, Goodman & Goodman. 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 1998-02-06.
- Submission: K974626
- Applicant / Sponsor: Goodman, Goodman & Goodman
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5880
- Decision date: 1998-02-06
Classification & Regulation
This clearance is catalogued under FDA product code JFB and 21 CFR 890.5880, within the Physical Medicine review panel as a Class II device.