Cleared Traditional

MOBILIZER

K840551 · Lossing Orthopedic, Inc. · Physical Medicine
Mar 1984
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K840551 is an FDA 510(k) clearance for the MOBILIZER, 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 March 23, 1984, 44 days after receiving the submission on February 8, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K840551 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1984
Decision Date March 23, 1984
Days to Decision 44 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