WAVELENGHT ULTRASOUND LOTION

K013212 · National Therapy Products, Inc. · MUI · Feb 25, 2002 · Radiology

Device Facts

• Record ID: K013212
• Device Name: WAVELENGHT ULTRASOUND LOTION
• Applicant: National Therapy Products, Inc.
• Product Code: MUI · Radiology
• Decision Date: Feb 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors. Apply Wavelength to treatment area. Remove after treatment with tissue or towels after use. For external use only.

Device Story

Wavelength Ultrasound Lotion functions as a conductive coupling medium for ultrasonic transducers. Applied topically to the treatment area to facilitate acoustic transmission between the transducer and patient skin; removed with tissue or towels post-procedure. Used in clinical settings by healthcare professionals during diagnostic or therapeutic ultrasound applications. Benefits include improved signal quality and acoustic coupling. Not for use with defibrillators.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Conductive lotion/gel medium for acoustic coupling. Non-sterile, topical application. No electronic components, software, or energy source.

Indications for Use

Indicated for use as a conductive medium for diagnostic and therapeutic ultrasonic transducers and ultrasound monitors. Contraindicated for use with defibrillators.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The symbol is a stylized depiction of a human figure embracing a bird. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2002

Mr. Paul L. Hooey President National Therapy Products, Inc. 2-191 Rowntree Dairy Road Woodbridge, Ontario, L4L 8B8 CANADA

Re: K013212

Trade/Device Name: Wavelength Ultrasound Lotion Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 MUI Dated: February 8, 2002 Received: February 11, 2002

Dear Mr. Hooey:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutleation. The I Dr I mailing of castion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific advice 101 your an of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions 01 (301-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by relected to promation the Act may be obtained from the Division of Small Manufacturers, your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Croydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K013212
Device Name: WAVELENGTH ULTRASOUND LOTION

Indications For Use:

Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic Waveleugur Ultrasound Dotton's a co- . This device is intended to be used as and therapedite ultrasonic transducers and ultrasound monitors.

Apply Wavelength to treatment area. Remove after treatment with tissue or Apply Wavelength to treatment arowels after use. For external use only.

Contraindications: Not for use with defibrillators

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sig Division of Repro and Radiological D 510(k) Num Over-The-Counter Use______ ાર Prescription Use_ (Optional Format 1-2-96 (Per 21 CFR 801 109)