Cleared Traditional

MOBILIMB J1 TMJ CPM UNIT (K895720) - FDA 510(k) Clearance

Class I Physical Medicine device.

K895720 · Toronto Medical Corp. · Physical Medicine device
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Jan 1990
Decision
101d
Days
Class 1
Risk

K895720 is an FDA 510(k) clearance for the MOBILIMB J1 TMJ CPM UNIT. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Toronto Medical Corp. (Canada L1w2y5, CA). The FDA issued a Cleared decision on January 4, 1990 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Toronto Medical Corp. devices

Submission Details

510(k) Number K895720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date January 04, 1990
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.