Clearance Summary
THE SIGNATURE SERIES, IMC IV received FDA 510(k) clearance under submission number K933194, sponsored by Progressive Electrical Therapeutics. 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 1994-07-13.
- Submission: K933194
- Applicant / Sponsor: Progressive Electrical Therapeutics
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1994-07-13
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.