Cleared Traditional

K851177 - UNIVERSAL POWER FLEX

K851177 is an FDA 510(k) clearance for UNIVERSAL POWER FLEX, manufactured by Biodynamic Technologies, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851177 · Biodynamic Technologies, Inc. · Physical Medicine device
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Jun 1985
Decision
95d
Days
Class 1
Risk

K851177 is an FDA 510(k) clearance for the UNIVERSAL POWER FLEX. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 95 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 Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K851177

510(k) Number K851177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1985
Decision Date June 28, 1985
Days to Decision 95 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
20d faster than avg
Panel avg: 115d · This submission: 95d
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 33
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K851177.
HIP CONTINUOUS PASSIVE MOTION MACHINE
K862314 · Richards Medical Co., Inc. · Jul 1986
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