Cleared Traditional

BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (K052625) - FDA 510(k) Clearance

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

K052625 · Bionicare Medical Technologies, Inc. · Neurology device
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Dec 2005
Decision
73d
Days
Class 2
Risk

K052625 is an FDA 510(k) clearance for the 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 December 5, 2005 after a review of 73 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 Bionicare Medical Technologies, Inc. devices

Submission Details

510(k) Number K052625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2005
Decision Date December 05, 2005
Days to Decision 73 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
75d faster than avg
Panel avg: 148d · This submission: 73d
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.