Clearance Summary
MOTO-MED RF-II AND PICO received FDA 510(k) clearance under submission number K893924, sponsored by Holl Meditronics, Inc.. 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 1990-11-27.
- Submission: K893924
- Applicant / Sponsor: Holl Meditronics, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1990-11-27
Classification & Regulation
This clearance is catalogued under FDA product code BXB and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.