Cleared Traditional

K960433 - VST-10, VST-10/2

K960433 is an FDA 510(k) clearance for VST-10, manufactured by Vcare Intl., Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K960433 · Vcare Intl., Inc. · Physical Medicine device
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May 1996
Decision
111d
Days
Class 2
Risk

K960433 is an FDA 510(k) clearance for the VST-10, VST-10/2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Vcare Intl., Inc. (Washington, D.C., US). The FDA issued a Cleared decision on May 21, 1996 after a review of 111 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 Vcare Intl., Inc. devices

FDA 510(k) Submission Details - K960433

510(k) Number K960433 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 31, 1996
Decision Date May 21, 1996
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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 249
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K960433.
ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
K960457 · Med Labs, Inc. · Sep 1996
HANDMASTER NMS1
K952273 · Neuromusclar Electrical Stimulation Systems, Ltd. · May 1996
STIM-8
K955736 · Bmr , Ltd. · May 1996
AXIOM-HVG
K955146 · Axiom Manufacturing · May 1996
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996
ULTRA IV
K960489 · Excel Tech. , Ltd. · Mar 1996