PAINSHIELD MD

K081075 · Nano Vibronix , Ltd. · PFW · Aug 22, 2008 · Physical Medicine

Device Facts

• Record ID: K081075
• Device Name: PAINSHIELD MD
• Applicant: Nano Vibronix , Ltd.
• Product Code: PFW · Physical Medicine
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PainShield™ MD diathermy device is intended to apply ultrasounic 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 Story

PainShield™ MD is an ultrasonic diathermy device for deep tissue heating. It generates continuous wave ultrasound at 90 kHz via a transducer/applicator patch that adheres to the skin like a bandage. The system includes the applicator, a rechargeable battery-powered driver unit, and a connecting cable. The device is designed for use by patients during normal daily activities as prescribed by a physician. The self-adhering patch allows for hands-free operation, eliminating the need for a therapist to hold the applicator. The device provides localized ultrasound energy transfer to areas such as the heel, Achilles tendon, and wrist. By enabling treatment during daily activities, it improves patient convenience while maintaining therapeutic functionality. The low energy levels prevent tissue overheating, and the design ensures the operator is not exposed to therapeutic ultrasound.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic diathermy device; 90 kHz continuous wave ultrasound; rechargeable battery-powered driver; self-adhering transducer/applicator patch (approx. 6 cm² area); complies with FDA standards for ultrasonic therapy products.

Indications for Use

Indicated for patients requiring deep heat therapy for relief of pain, muscle spasms, and joint contractures. Prescription use only.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Predicate Devices

• Duo-Son Ultrasonic Diathermy Device (K970131)

Submission Summary (Full Text)

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K04/075-

## Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### Submitter:

NanoVibronix Ltd., 47 Hataasia St. P.O.B. 515 Nesher 36603, Israel Tcl: +972.4.82().1994; Fax:[phone] e-mail: [e-mail]

Name of the Device: PainShield™ MD.

Predicate Devices: The PainShield™ MD is substantially equivalent to the Duo-Son Ultrasonic Diathermy Device manufactured by Orthosonics Ltd., subject of k970131.

Description of the Device: The PainShield™ MD is an ultrasonic diathermy device used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a patch that adheres to the skin, as does a bandage.The PainShield™ MD is used to generate continuous wave ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicator allows treatment of less accessible body parts such as, for example, the heel, the achilles tendon and the wrist. The device includes the above-mentioned transducer, a small, rechargeable, battery-powered driver unit and a cable that connects the driver to the transducer.

The Painshield™ MD device maintains the functionality of existing ultrasonic diathermy devices and also has the following advantages:

1. Small external dimensions and light weight,

2. User-friendly construction,

3. Because the applicator patch self-adheres to the skin, the physician's or therapist's hands are freed and he/she does not need to concentrate on and personally hold the applicator adjacent to the patient's body during the treatment session,

4. The low energy levels assure no overheating of the underlying tissue,

5. The applicator has an increased local concentration of ultrasound energy transfer due to the fixed adherence of the applicator to the treatment area,

6. Device characteristics assure that the operator is not exposed to therapeutic ultrasound,

7. Device characteristics, i.e., weight, dimensions and self-adherence, allow a patient to go about his/her normal daily activities while receiving treatment, as prescribed by the physician.

The Painshield™ MD complies with the FDA standard for ultrasonic therapy products.

April 14, 2008

Harold Jaffe

Dr. Harold Jacob, President

Date

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2014

NanoVibronix Ltd. c/o Dr. Eli M. Orbach International Regulatory Consultants POB 6718 Efrat 90435 Israel

Re: K081075 Trade/Device Name: PainShield™ MD Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: II Product Code: PFW Dated: June 1, 2008 Received: June 5, 2008

Dear Dr. Orbach:

This letter corrects our substantially equivalent letter of August 22, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

- Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 – Dr. Eli M. Orbach

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whanq -S

for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use (separate page):

Page 1 of 1 510(k) Number (if known)_ K081075

Device Name____ The PainShield™ MD

Indications For Use:

The PainShield"M MD diathermy device is intended to apply ultrasounic 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Yes Over The Counter Use_ No (Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off) eneral, Restorative, Division of G and Neurolog 510(k) Number

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