Cleared Traditional

K923262 - DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER

K923262 is an FDA 510(k) clearance for DMG100 AND 500 ISOMETRIC STRENGTH DYNAM..., manufactured by John Chatillon & Sons, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K923262 · John Chatillon & Sons, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
117d
Days
Class 2
Risk

K923262 is an FDA 510(k) clearance for the DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by John Chatillon & Sons, Inc. (Greensboro, US). The FDA issued a Cleared decision on October 27, 1992 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K923262

510(k) Number K923262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date October 27, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 149d · This submission: 117d
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 32
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K923262.
NK GRASP SENSOR, MODEL GA001
K923964 · Nk Biotechnical Engineering Co. · May 1993
NK GRASP SENSOR, MODEL GA002
K923965 · Nk Biotechnical Engineering Co. · May 1993
NK DIGI-GRIP SENSOR, MODEL DGR001
K923963 · Nk Biotechnical Engineering Co. · Mar 1993
REMUSK MP
K922029 · Equipement Biomedical Specialise, Inc. · Oct 1992
CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002
K922940 · Exos, Inc. · Oct 1992
NK DYNA-GRIP SENSOR, MODEL DG001
K921268 · Nk Biotechnical Engineering Co. · Jul 1992
K923262 · DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER
Download PDF FDA Summary John Chatillon & Sons…