Cleared Traditional

BX-1000 ISOMATIC (K820080) - FDA 510(k) Clearance

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

K820080 · Bloomex International, Inc. · Physical Medicine device
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Jul 1982
Decision
170d
Days
Class 2
Risk

K820080 is an FDA 510(k) clearance for the BX-1000 ISOMATIC. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bloomex International, Inc. (7600 Ridge Blvd Brooklun, US). The FDA issued a Cleared decision on July 1, 1982 after a review of 170 days - an extended review cycle.

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 Bloomex International, Inc. devices

Submission Details

510(k) Number K820080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1982
Decision Date July 01, 1982
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
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 K820080.
NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984
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