Cleared Traditional

K922270 - PHYSIOTECH 4000 OR NORODYN 8000

K922270 is an FDA 510(k) clearance for PHYSIOTECH 4000 OR NORODYN 8000, manufactured by Myo-Tronics, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 841-day FDA review.

K922270 · Myo-Tronics, Inc. · Neurology device
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Sep 1994
Decision
841d
Days
Class 2
Risk

K922270 is an FDA 510(k) clearance for the PHYSIOTECH 4000 OR NORODYN 8000. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Myo-Tronics, Inc. (Seattle, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 841 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K922270

510(k) Number K922270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date September 02, 1994
Days to Decision 841 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
692d slower than avg
Panel avg: 149d · This submission: 841d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 172
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K922270.
NEUROSEARCH-4
K920038 · Lexicor · Feb 1995
RELAXOMAT
K925750 · Relaxomat, Inc. · Jan 1995
EMG TRAINER
K935853 · Unitech · Jan 1995
THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
K941938 · Intercare Diagnostics, Inc. · Aug 1994
MEDAC SYSTEM/3
K914925 · Davicon, Inc. · Oct 1993
NORODYN 2000 ELECTROMYOGRAPH
K922838 · Noromed, Inc. · Sep 1993
K922270 · PHYSIOTECH 4000 OR NORODYN 8000
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