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MODIFIED PENOX LIFT CHAIR

K862654 Class II Traditional
Decision Date
1986-07-18
Sponsor / Applicant
Penox Technologies, Inc.

Technical Specification

510(k) Submission ID K862654
Product Code INO
Medical Specialty / Panel Physical Medicine
Regulation Citation 21 CFR 890.3110
Decision Date 1986-07-18
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MODIFIED PENOX LIFT CHAIR received FDA 510(k) clearance under submission number K862654, sponsored by Penox Technologies, 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 1986-07-18.

Classification & Regulation

This clearance is catalogued under FDA product code INO and 21 CFR 890.3110, within the Physical Medicine review panel as a Class II device.