Cleared Traditional

K790120 - SLENDERTONE

K790120 is an FDA 510(k) clearance for SLENDERTONE, manufactured by Bloomex International, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K790120 · Bloomex International, Inc. · Physical Medicine device
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May 1979
Decision
104d
Days
Class 2
Risk

K790120 is an FDA 510(k) clearance for the SLENDERTONE. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bloomex International, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1979 after a review of 104 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 Bloomex International, Inc. devices

FDA 510(k) Submission Details - K790120

510(k) Number K790120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1979
Decision Date May 07, 1979
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

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 190
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K790120.
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064 · Zimmer, Inc. · Dec 1980
INTELECT
K801790 · Chattanooga Group, Inc. · Aug 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980
HVG-100
K790033 · Elmed, Inc. · Feb 1979
MUSCLE STIMULATOR, ELECTRICAL
K781113 · Rich-Mar Corp. · Sep 1978
STEMPLEX
K781167 · Rich-Mar Corp. · Sep 1978