Cleared Traditional

K935587 - MULTILINK SHOULDER CPM UNIT

K935587 is the FDA 510(k) clearance for MULTILINK SHOULDER CPM UNIT by Toronto Medical Corp.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K935587 · Toronto Medical Corp. · Physical Medicine device
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Dec 1994
Decision
393d
Days
Class 1
Risk

K935587 is an FDA 510(k) clearance for the MULTILINK SHOULDER 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 December 14, 1994 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K935587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date December 14, 1994
Days to Decision 393 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
278d slower than avg
Panel avg: 115d · This submission: 393d
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.

Regulatory Peers - BXB Exerciser, Powered

All 31
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K935587.
R & D BATTERIES, INC. PART NUMBER 5447
K935467 · R & D Batteries, Inc. · Apr 1994
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
K926313 · Henley Intl. · Feb 1994
ARTROMOT MULTI DIRECTIONAL ANKLE CPM
K924484 · Buckman Co., Inc. · Mar 1993
ARTROMOT SB ELBOW ATTACHMENT
K923857 · Buckman Co., Inc. · Feb 1993
DANNINFLEX CPM 800
K923216 · Buckman Co., Inc. · Aug 1992
DANNIFLEX CPM 2000
K923217 · Buckman Co., Inc. · Aug 1992