Cleared Traditional

K952680 - VARAPULSE-2

K952680 is an FDA 510(k) clearance for VARAPULSE-2, manufactured by Staodyne, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K952680 · Staodyne, Inc. · Physical Medicine device
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Dec 1995
Decision
175d
Days
Class 2
Risk

K952680 is an FDA 510(k) clearance for the VARAPULSE-2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Staodyne, Inc. (Longmont, US). The FDA issued a Cleared decision on December 4, 1995 after a review of 175 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 Staodyne, Inc. devices

FDA 510(k) Submission Details - K952680

510(k) Number K952680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date December 04, 1995
Days to Decision 175 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
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 273
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