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510(k) Data Aggregation
K Number
K221210Device Name
PainShield MD PLUS
Manufacturer
NanoVibronix, Inc.
Date Cleared
2022-11-23
(210 days)
Product Code
PFW
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
NanoVibronix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
Device Description
The PainShield MD PLUS is an electrically powered ultrasonic diathermy device intended to relieve pain, muscle spasms, and joint contractures. It is used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a bandage-like patch that adheres to the skin.
The PainShield MD PLUS is used to generate continuous wave (CW) ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicators allow treatment of less accessible body parts such as, for example, the heel, the Achilles tendon and the wrist. The device includes the above-mentioned transducers with a cable which connects to a small, rechargeable, battery-powered driver unit and self-adhering patch to apply the transducer on to the skin. The unit is also supplied with a charger used for recharging the battery. Ultrasonic gel is typically not required to be used with the PainShield MD PLUS device. However, for treatment over hairy sites where there might not be adequate sonic coupling between the applicator and the skin, users are instructed to apply standard, FDA-cleared ultrasound gel to the site to improve coupling.
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