Cleared Special

MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (K030332) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030332 · Bionicare Medical Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
126d
Days
Class 2
Risk

K030332 is an FDA 510(k) clearance for the MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000. Classified as Stimulator, Electrical, Transcutaneous, For Arthritis (product code NYN), Class II - Special Controls.

Submitted by Bionicare Medical Technologies, Inc. (Sparks, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bionicare Medical Technologies, Inc. devices

Submission Details

510(k) Number K030332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2003
Decision Date June 06, 2003
Days to Decision 126 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Modification to existing cleared device.

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.