Cleared Traditional

K851331 - EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)

K851331 is an FDA 510(k) clearance for EMPI MODEL 100, manufactured by Empi. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K851331 · Empi · Physical Medicine device
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Jul 1985
Decision
104d
Days
Class 1
Risk

K851331 is an FDA 510(k) clearance for the EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT). Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Empi (Minneapolis, US). The FDA issued a Cleared decision on July 17, 1985 after a review of 104 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 Empi devices

FDA 510(k) Submission Details - K851331

510(k) Number K851331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date July 17, 1985
Days to Decision 104 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K851331.
KNEECPM
K864427 · Invacare Corp. · Dec 1986
HIP CONTINUOUS PASSIVE MOTION MACHINE
K862314 · Richards Medical Co., Inc. · Jul 1986
TOTAL CPM
K852399 · Invacare Corp. · Aug 1985
UNIVERSAL POWER FLEX
K851177 · Biodynamic Technologies, Inc. · Jun 1985
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
K850332 · Richards Medical Co., Inc. · May 1985
UNIFLEX DANNINGER
K843309 · Buckman Co., Inc. · Oct 1984