Cleared Traditional

PAINSHIELD MD (K081075) - FDA 510(k) Clearance

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

K081075 · Nano Vibronix , Ltd. · Physical Medicine device
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Aug 2008
Decision
128d
Days
Class 2
Risk

K081075 is an FDA 510(k) clearance for the PAINSHIELD MD. Classified as Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (product code PFW), Class II - Special Controls.

Submitted by Nano Vibronix , Ltd. (Efrat, IL). The FDA issued a Cleared decision on August 22, 2008 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 Nano Vibronix , Ltd. devices

Submission Details

510(k) Number K081075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2008
Decision Date August 22, 2008
Days to Decision 128 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
Definition Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation.
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 - PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

All 8
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