Cleared Traditional

K854761 - MINIPAC PERSONAL TOUCH (TM)

K854761 is an FDA 510(k) clearance for MINIPAC PERSONAL TOUCH (TM), manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K854761 · Medical Devices, Inc. · Neurology device
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Feb 1986
Decision
79d
Days
Class 2
Risk

K854761 is an FDA 510(k) clearance for the MINIPAC PERSONAL TOUCH (TM). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 14, 1986 after a review of 79 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K854761

510(k) Number K854761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date February 14, 1986
Days to Decision 79 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
69d faster than avg
Panel avg: 148d · This submission: 79d
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 140
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K854761.
EMPI MODEL 720 NMS, TENS
K861451 · Empi · Jul 1986
FASTENS(TM)
K854316 · Medical Devices, Inc. · Feb 1986
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · Valley Forge Scientific Corp. · Feb 1986
MINIPAC (TM)
K854317 · Medical Devices, Inc. · Jan 1986
SYS STIM 206 MODEL ME206
K851735 · Mettler Electronics Corp. · Nov 1985
TENSMED II
K851063 · Intermedics, Inc. · Jun 1985