Cleared Traditional

BACK ON TRACK INVERSION THERAPY & EXER

K823236 · Lossing Orthopedic, Inc. · Physical Medicine
Jan 1983
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K823236 is an FDA 510(k) clearance for the BACK ON TRACK INVERSION THERAPY & EXER, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Lossing Orthopedic, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983, 81 days after receiving the submission on November 1, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K823236 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1982
Decision Date January 21, 1983
Days to Decision 81 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ION — Exerciser, Non-measuring
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370