Clearance Summary
TABLE, EXAM & MANUPULATION received FDA 510(k) clearance under submission number K770636, sponsored by I E Industries. 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 1977-04-15.
- Submission: K770636
- Applicant / Sponsor: I E Industries
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3520
- Decision date: 1977-04-15
Classification & Regulation
This clearance is catalogued under FDA product code INT and 21 CFR 890.3520, within the Physical Medicine review panel as a Class I device.