Cleared Traditional

K951951 - FOCUS MODEL 795 UNIT

K951951 is an FDA 510(k) clearance for FOCUS MODEL 795 UNIT, manufactured by Empi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K951951 · Empi · Neurology device
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May 1996
Decision
387d
Days
Class 2
Risk

K951951 is an FDA 510(k) clearance for the FOCUS MODEL 795 UNIT. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on May 17, 1996 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Empi devices

FDA 510(k) Submission Details - K951951

510(k) Number K951951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1995
Decision Date May 17, 1996
Days to Decision 387 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 148d · This submission: 387d
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 228
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K951951.
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GALVA 5-T
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EPIX XL TENS UNIT
K951903 · Empi · Mar 1996
ACUPLUS
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