Cleared Traditional

K840963 - SD PLUS PATIENT CAT.#78-8010

K840963 is an FDA 510(k) clearance for SD PLUS PATIENT CAT.#78-8010, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K840963 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
48d
Days
Class 2
Risk

K840963 is an FDA 510(k) clearance for the SD PLUS PATIENT CAT.#78-8010. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 48 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K840963

510(k) Number K840963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1984
Decision Date April 23, 1984
Days to Decision 48 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
100d faster than avg
Panel avg: 148d · This submission: 48d
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 209
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K840963.
ELECTRO-NERVE STIMULATOR HL
K841184 · Biomedical Life Systems, Inc. · Oct 1984
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · Mentor Corp. · Aug 1984
NEURO PULSE
K841400 · Parker Laboratories, Inc. · Jun 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · Codman & Shurtleff, Inc. · Apr 1984
OBSTETRIC PULSAR TWO CHANNEL TENS
K840497 · Spembly Medical , Ltd. · Apr 1984
EMPI MODEL 984 BASIX, TENS
K841045 · Empi · Apr 1984