Cleared Traditional

K970696 - S.P. 100

K970696 is an FDA 510(k) clearance for S.P. 100, manufactured by Lsi Intl., Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K970696 · Lsi Intl., Inc. · Neurology device
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Mar 1997
Decision
21d
Days
Class 2
Risk

K970696 is an FDA 510(k) clearance for the S.P. 100. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Lsi Intl., Inc. (Overland Park, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 21 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 Lsi Intl., Inc. devices

FDA 510(k) Submission Details - K970696

510(k) Number K970696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1997
Decision Date March 18, 1997
Days to Decision 21 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
GORDON GILLERMAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K970696.
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
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BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
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EPIX VT
K970203 · Empi · Apr 1997
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
K963729 · Skylark Device Co., Ltd. · Feb 1997
SMART-TENS, MODEL 456
K961376 · Bio-Medical Research, Ltd. · Sep 1996
FOCUS MODEL 795 UNIT
K951951 · Empi · May 1996