Cleared Traditional

FIRM-A-TRON (K810634) - FDA 510(k) Clearance

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

K810634 · Biotron , Ltd. · Physical Medicine device
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Jun 1981
Decision
94d
Days
Class 2
Risk

K810634 is an FDA 510(k) clearance for the FIRM-A-TRON. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Biotron , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 94 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 Biotron , Ltd. devices

Submission Details

510(k) Number K810634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1981
Decision Date June 12, 1981
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K810634.
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279 · Medtronic Vascular · Nov 1982
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008 · Medtronic Vascular · Dec 1981
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064 · Zimmer, Inc. · Dec 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980