meddevicedb.com FDA Device Reference

FT MODEL TABLE W/ELECTRIC HI LO OPTION E

K925563 Class I Traditional
Decision Date
1993-05-26
Sponsor / Applicant
Pro Med Mfg., Inc.

Technical Specification

510(k) Submission ID K925563
Product Code INQ
Medical Specialty / Panel Physical Medicine
Regulation Citation 21 CFR 890.3760
Decision Date 1993-05-26
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

FT MODEL TABLE W/ELECTRIC HI LO OPTION E received FDA 510(k) clearance under submission number K925563, sponsored by Pro Med Mfg., 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 1993-05-26.

Classification & Regulation

This clearance is catalogued under FDA product code INQ and 21 CFR 890.3760, within the Physical Medicine review panel as a Class I device.