Cleared Traditional

K860226 - FORCE EVALUATION AND TESTING SYSTEM (FETS)

K860226 is an FDA 510(k) clearance for FORCE EVALUATION AND TESTING SYSTEM (FETS), manufactured by Hoggan Health Industries, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K860226 · Hoggan Health Industries, Inc. · Neurology device
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Mar 1986
Decision
64d
Days
Class 2
Risk

K860226 is an FDA 510(k) clearance for the FORCE EVALUATION AND TESTING SYSTEM (FETS). Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Hoggan Health Industries, Inc. (Draper, US). The FDA issued a Cleared decision on March 27, 1986 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K860226

510(k) Number K860226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date March 27, 1986
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 149d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - LBB Dynamometer, Ac-powered

All 35
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K860226.
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS
K884165 · Spark Instruments & Academics, Inc. · Oct 1988
KIN-COM JR
K881388 · Chattanooga Group, Inc. · Apr 1988
DYNATRON II
K880464 · Dynatronics Laser Corp. · Mar 1988
DIGITAL GRIP/PINCH STRENGTH METOR
K850697 · Chattanooga Group, Inc. · May 1985
MED-EX
K812899 · Chattanooga Group, Inc. · Nov 1981
MYO-METRIC II
K811312 · Mycron Medical, Inc. · Jun 1981
K860226 · FORCE EVALUATION AND TESTING SYSTEM (FETS)
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