Clearance Summary
DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER received FDA 510(k) clearance under submission number K872199, sponsored by Dyno-Max 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 1987-08-21.
- Submission: K872199
- Applicant / Sponsor: Dyno-Max Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1925
- Decision date: 1987-08-21
Classification & Regulation
This clearance is catalogued under FDA product code IKK and 21 CFR 890.1925, within the Physical Medicine review panel as a Class II device.