Cleared Special

K221210 - PainShield MD PLUS (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221210 · Nanovibronix, Inc. · Physical Medicine device
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Nov 2022
Decision
210d
Days
Class 2
Risk

K221210 is an FDA 510(k) clearance for the PainShield MD PLUS. Classified as Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (product code PFW), Class II - Special Controls.

Submitted by Nanovibronix, Inc. (Elmsford, US). The FDA issued a Cleared decision on November 23, 2022 after a review of 210 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nanovibronix, Inc. devices

Submission Details

510(k) Number K221210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2022
Decision Date November 23, 2022
Days to Decision 210 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 115d · This submission: 210d
Pathway characteristics
Modification to existing cleared device.

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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