Cleared Traditional

K832805 - BIONICARE STIMULATOR BIO-1

K832805 is the FDA 510(k) clearance for BIONICARE STIMULATOR BIO-1 by Murray Electronics. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K832805 · Murray Electronics · Physical Medicine device
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Dec 1983
Decision
127d
Days
Class 2
Risk

K832805 is an FDA 510(k) clearance for the BIONICARE STIMULATOR BIO-1. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Murray Electronics (Mchenry, US). The FDA issued a Cleared decision on December 23, 1983 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Murray Electronics devices

Submission Details

510(k) Number K832805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date December 23, 1983
Days to Decision 127 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 157
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K832805.
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · Richards Medical Co., Inc. · Apr 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984
NEUROMUSCLAR II
K840346 · Mentor Corp. · Feb 1984
RICH-MAR HV 20
K830055 · Rich-Mar Corp. · Mar 1983
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279 · Medtronic Vascular · Nov 1982
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
K820168 · Mentor Corp. · Feb 1982