Cleared Traditional

K821255 - ELECTRODYNOGRAM SYSTEM

K821255 is an FDA 510(k) clearance for ELECTRODYNOGRAM SYSTEM, manufactured by The Langer Group. The device is a Class 1 Physical Medicine device with product code KHX cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K821255 · The Langer Group · Physical Medicine device
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Jul 1982
Decision
63d
Days
Class 1
Risk

K821255 is an FDA 510(k) clearance for the ELECTRODYNOGRAM SYSTEM. Classified as Platform, Force-measuring (product code KHX), Class I - General Controls.

Submitted by The Langer Group (Walker, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1575 - 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: 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 - K821255

510(k) Number K821255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1982
Decision Date July 02, 1982
Days to Decision 63 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
53d faster than avg
Panel avg: 116d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

KHX Device Classification - Class 1, General Controls

Product Code KHX Platform, Force-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1575
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 - KHX Platform, Force-measuring

All 14
Devices cleared under the same product code (KHX) and FDA review panel - the closest regulatory comparables to K821255.
BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM
K883198 · Advanced Mechanical Technology, Inc. · Oct 1988
MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY
K883127 · Advanced Mechanical Technology, Inc. · Sep 1988
DUAL FORCEPLATE
K863443 · Neurocom International, Inc. · Sep 1986
HEART-ALERT
K820444 · Medical Equipment Devices, Inc. · Mar 1982
K821255 · ELECTRODYNOGRAM SYSTEM
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