Cleared Traditional

K965187 - SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD

K965187 is an FDA 510(k) clearance for SPECTRUM II, manufactured by Sparta Surgical Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K965187 · Sparta Surgical Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
220d
Days
Class 2
Risk

K965187 is an FDA 510(k) clearance for the SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Sparta Surgical Corp. (Great Neck,, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 220 days - an extended review 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: 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.

View all Sparta Surgical Corp. devices

FDA 510(k) Submission Details - K965187

510(k) Number K965187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date August 01, 1997
Days to Decision 220 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
72d slower than avg
Panel avg: 148d · This submission: 220d
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 183
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K965187.
RELIEFBAND
K980333 · Woodside Biomedical, Inc. · Feb 1998
INTELECT
K974497 · Chattanooga Group, Inc. · Jan 1998
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
K965244 · Z Technologies, LLC · Aug 1997
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K970429 · Apex Medical Corp. · Apr 1997
EPIX VT
K970203 · Empi · Apr 1997
S.P. 100
K970696 · Lsi Intl., Inc. · Mar 1997