Cleared Traditional

K983228 - BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000

K983228 is an FDA 510(k) clearance for BIONICARE STIMILATOR SYSTEM, manufactured by Murray Electronics. The device is a Class 2 Neurology device with product code NYN cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K983228 · Murray Electronics · Neurology device
Download Printable Device Report (PDF)
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.

View all Murray Electronics devices

FDA 510(k) Submission Details - K983228

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
Combination Product No
PCCP Authorized No
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.

NYN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NYN Stimulator, Electrical, Transcutaneous, For Arthritis

Devices cleared under the same product code (NYN) and FDA review panel - the closest regulatory comparables to K983228.
JOINT STIM, MODEL 1000
K073386 · Pain Management Technologies · Jul 2008
RS-4I MUSCLE STIMULATOR FAMILY
K062325 · Rs Medical · Apr 2007
BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
K052625 · Bionicare Medical Technologies, Inc. · Dec 2005
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
K971437 · Murray Electronics · Jul 1997