Cleared Traditional

BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 (K983228) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983228 · Murray Electronics · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
181d
Days
Class 2
Risk

K983228 is an FDA 510(k) clearance for the BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000. Classified as Stimulator, Electrical, Transcutaneous, For Arthritis (product code NYN), Class II - Special Controls.

Submitted by Murray Electronics (Hunt Valley, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 181 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K983228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date March 15, 1999
Days to Decision 181 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Electrical Stimulation Unit With Leads And Cutaneous Electrodes Used To Apply An Electrical Current Through Electrodes On Patient's Skin To Provide Relief Of Pain Associated With Arthritis (including Osteoarthritis And Rheumatoid Arthritis).
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.