(279 days)
Not Found
No
The device description details mechanical and ultrasonic mechanisms, with no mention of AI or ML algorithms for control, analysis, or operation. The "Computerized" aspect likely refers to electronic control of the vacuum pump and electrovalves, not AI/ML.
Yes
The device is indicated for therapeutic uses such as pain relief, muscle spasm relief, and improving local blood circulation, aligning with the definition of a therapeutic device.
No
The device is described as a massager and an ultrasonic diathermy system, used for therapeutic purposes such as temporary relief of muscle aches, pains, spasms, and cellulite, and for producing thermal changes in tissues. None of the listed functions involve identifying or characterizing a disease or condition.
No
The device description clearly outlines physical hardware components including a membrane, vacuum pump, electrovalves, and an ultrasonic handpiece, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is a physical therapy device that applies massage and ultrasound directly to the body. It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are for therapeutic purposes (pain relief, muscle spasms, circulation, cellulite reduction) and are applied externally.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IMI, ISA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)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.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
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.
Via della Gora 13/1-15/19
50025 Montespertoli, Florence
Italy |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | August 1, 2006 |
- Names
| Device Name: | MED Sculpt Computerized Body Massager
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
1
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.
2
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.
3
Page 2 -
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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