Cleared Traditional

K823497 - WRIGHT CARE

K823497 is an FDA 510(k) clearance for WRIGHT CARE, manufactured by Dow Corning Wright. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K823497 · Dow Corning Wright · Neurology device
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Jan 1983
Decision
45d
Days
Class 2
Risk

K823497 is an FDA 510(k) clearance for the WRIGHT CARE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Dow Corning Wright (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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.

View all Dow Corning Wright devices

FDA 510(k) Submission Details - K823497

510(k) Number K823497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date January 07, 1983
Days to Decision 45 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
103d faster than avg
Panel avg: 148d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 139
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K823497.
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983
SPEC IISX
K831413 · Medical Devices, Inc. · Jun 1983
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K823002 · Tri W-G, Inc. · Nov 1982
NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K813501 · Empi · Dec 1981