MED SCULPT

K053041 · General Project S.R.L. · IMI · Aug 2, 2006 · Physical Medicine

Device Facts

• Record ID: K053041
• Device Name: MED SCULPT
• Applicant: General Project S.R.L.
• Product Code: IMI · Physical Medicine
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for: a. Therapeutic Massager: Provides temporary relief of minor muscle aches and pains . - Relieves muscle spasms ii. iii. Temporarily improves local blood circulation Temporarily reduces the appearance of cellulite iv. b. Ultrasonic Diathermy: i. Relief of pain Muscle spasms ii. Joint contractures iii. NOT for the treatment of malignancies iv.

Device Story

System combines therapeutic massage and ultrasound diathermy. Massage component utilizes elastomeric membrane on handpiece; vacuum pump creates changeable depression; electronically controlled electrovalves regulate membrane movement. Ultrasound component uses 3 MHz fixed frequency handpiece to generate mechanical energy; increases molecular vibration in tissue; produces thermal changes. Used in clinical settings; operated by healthcare professionals. Output provides thermal therapy and mechanical massage to target areas; aids in pain relief and muscle spasm reduction.

Clinical Evidence

No clinical data presented.

Technological Characteristics

System includes massage handpiece with elastomeric membrane and vacuum pump; ultrasonic handpiece operating at fixed 3 MHz frequency. Energy source: electrical. Connectivity: not specified. Sterilization: not specified. Software: electronically controlled electrovalves for vacuum regulation.

Indications for Use

Indicated for relief of minor muscle aches, pains, and spasms; temporary improvement of local blood circulation; temporary reduction of cellulite appearance; relief of pain, muscle spasms, and joint contractures via ultrasonic diathermy. Contraindicated for treatment of malignancies.

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

• Dermosonic (K024307)

Submission Summary (Full Text)

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K053041

# 510(k) Summary of Safety and Effectiveness for the MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

#### 1. General Information

# AUG 0 2 2006

| Submitter: | General Project, S.r.l.<br>Via della Gora 13/1-15/19<br>50025 Montespertoli, Florence<br>Italy |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | August 1, 2006 |

2. Names

| Device Name: | MED Sculpt Computerized Body Massager<br>and M-Sonic Ultrasound Diathermy |
|----------------------|---------------------------------------------------------------------------|
| Classification Name: | Therapeutic Massager and Ultrasonic |

#### 3. Predicate Devices

The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is substantially equivalent to the Dermosonic, manufactured by Sybaritic, Inc. (K024307).

Diathermy

Product Code: IMI, ISA

## 4. Device Description

The MED SCULPT Computerized Body Massager and M-Sonic Ultrasound Diathermy system has massage and ultrasound diathermy components. The massage portion of the device uses a specially designed membrane, made up of elastomeric material. This membrane, fastened onto the handbiece, moves in an alternate way due to changeable depression created by a vacuum pump; such movement is due to the opening and closing of two electronically controlled electrovalves. The unit also includes an ultrasonic handpiece that can be used to perform ultrasound diathermy. Ultrasound is a particular form of mechanical energy which leads to an increase in the molecular vibration of the tissue resulting in heat generation and according to this principle the ultrasonic

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handpiece of the unit, using an ultrasound wave at the fixed frequency of 3 MHz, produces thermal changes in the areas of the body where it is applied.

#### 5. Indications for Use

The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for:

- a. Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains . -
- Relieves muscle spasms ii.
- iii. Temporarily improves local blood circulation
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy:
- i. Relief of pain
- Muscle spasms ii.
- Joint contractures iii.
- NOT for the treatment of malignancies iv.

## 6. Performance Data

None presented.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services, featuring three curved lines or shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

General Project S.r.l. C/O Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K053041

Trade/Device Name: MED Sculpt Computerized Body Massage and M-Sonic Ultrasound Diathermy Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI and ISA Dated: June 28, 2006 Received: June 29, 2006

Dear Ms. O'Connell:

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 such 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 Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation vor); [ed, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ontain 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/cdrl/industry/support/index.html

Sincerely yours,

Helmut Remens

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy

Indications for Use:

The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for:

- a. Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains i.
- ii . Relieves muscle spasms
- iii. Temporarily improves local blood circulation
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy:
- Relief of pain i.
- ii. Muscle spasms
- III. Joint contractures
- NOT for the treatment of malignancies iv.

Prescription Use × - AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lewis

on Sign-Off Division of General, Restorative, age _1_ of _1_ and Neurological Devices

510(k) Number