Cleared Traditional

K844995 - SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEV...

K844995 is the FDA 510(k) clearance for SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEV... by Cropper Medical, Inc.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K844995 · Cropper Medical, Inc. · Physical Medicine device
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Apr 1985
Decision
96d
Days
Class 1
Risk

K844995 is an FDA 510(k) clearance for the SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Cropper Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 96 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 Cropper Medical, Inc. devices

Submission Details

510(k) Number K844995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date April 01, 1985
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
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 K844995.
TOTAL CPM
K852399 · Invacare Corp. · Aug 1985
EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)
K851331 · Empi · Jul 1985
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
K850332 · Richards Medical Co., Inc. · May 1985
UNIFLEX DANNINGER
K843309 · Buckman Co., Inc. · Oct 1984
PATIENT GUIDED KNEE EXERCISER
K843493 · Richards Medical Co., Inc. · Sep 1984
CONTINUOUS PASSIVE MOTION
K841674 · Chattanooga Group, Inc. · May 1984