Cleared Traditional

K882631 - EMPI MODEL 727,NMS

K882631 is an FDA 510(k) clearance for EMPI MODEL 727, manufactured by Empi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K882631 · Empi · Neurology device
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Sep 1988
Decision
87d
Days
Class 2
Risk

K882631 is an FDA 510(k) clearance for the EMPI MODEL 727,NMS. 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 September 22, 1988 after a review of 87 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.

FDA 510(k) Submission Details - K882631

510(k) Number K882631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date September 22, 1988
Days to Decision 87 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
62d faster than avg
Panel avg: 149d · This submission: 87d
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 557
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K882631.
HEPAX (TENS)
K882154 · Avl Scientific Corp. · Sep 1988
TENSTAR
K874818 · Healthcheck Corp. · Sep 1988
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
K875072 · Amana Medical Group · Sep 1988
ELECTROSTIMULATOR MODEL 808
K880426 · Cornell Enterprises Co., Inc. · Sep 1988
ALPHA-STIM 350
K881753 · Electromedical Products, Inc. · Aug 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · Medical Devices, Inc. · Aug 1988
K882631 · EMPI MODEL 727,NMS
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