Cleared Traditional

K913522 - SOLITENS MODIFIED

K913522 is an FDA 510(k) clearance for SOLITENS MODIFIED, manufactured by Innovative Designer Products, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K913522 · Innovative Designer Products, Inc. · Neurology device
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Aug 1991
Decision
33d
Days
Class 2
Risk

K913522 is an FDA 510(k) clearance for the SOLITENS MODIFIED. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Innovative Designer Products, Inc. (Glen Rock, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 33 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 Innovative Designer Products, Inc. devices

FDA 510(k) Submission Details - K913522

510(k) Number K913522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1991
Decision Date August 28, 1991
Days to Decision 33 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 148d · This submission: 33d
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 291
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