Cleared Traditional

K840551 - MOBILIZER

K840551 is the FDA 510(k) clearance for MOBILIZER by Lossing Orthopedic, Inc.. It is a Class 1 Physical Medicine device (product code ION) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K840551 · Lossing Orthopedic, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
44d
Days
Class 1
Risk

K840551 is an FDA 510(k) clearance for the MOBILIZER. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Lossing Orthopedic, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5370 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lossing Orthopedic, Inc. devices

Submission Details

510(k) Number K840551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ION Exerciser, Non-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ION Exerciser, Non-measuring

All 25
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K840551.
KNEE WALKER
K833870 · Maddak, Inc. · Nov 1983
PEDAL EXERCISER
K832968 · Maddak, Inc. · Sep 1983
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
K831543 · Fred Sammons, Inc. · Jun 1983
DELUXE ADJUST-ANGLE BOARD-BK4066
K831538 · Fred Sammons, Inc. · Jun 1983
MADDATRAINER HAND EXERCISER
K830400 · Maddak, Inc. · Mar 1983
INFLATABLE HEAVY PLASTIC EXERCISER
K823623 · Fred Sammons, Inc. · Dec 1982