Clearance Summary
DIGITAL ELECTRONIC EXERCISER/PULSE MTR. received FDA 510(k) clearance under submission number K800072, sponsored by Sears, Roebuck & Co.. 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 1980-01-28.
- Submission: K800072
- Applicant / Sponsor: Sears, Roebuck & Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 1980-01-28
Classification & Regulation
This clearance is catalogued under FDA product code ISD and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.