(190 days)
Indications for use include the following:
a. Therapeutic Massager:
i. Provides temporary relief of minor muscle aches and pains
ii. Relieves muscle spasms
iii. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy :
i. Relief of pain
ii. Muscle spasms
iii. Joint contractures
iv. NOT for the treatment of malignancies
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies in the context of an AI/algorithm-based device.
The document is an FDA 510(k) clearance letter for a device called "Dermosonic Non-Invasive Subdermal Therapy System". It describes the device's indications for use and states that it has been found "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot fulfill your request as the necessary information is not present in the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or figures, stacked on top of each other.
Public Health Service
2 2003 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Randall E. Berglund, General Counsel Sybaritic, Inc. 9220 James Avenue South Minneapolis, Minnesota 55431
Re: K024307
Trade/Device Name: Dermosonic Non-Invasive Subdermal Therapy System Regulation Number: 21 CFR 890.5300, 21 CFR 890.5660 Regulation Name: diathermy, ultrasonic; massager, therapeutic Regulatory Class: Class II, Class I Product Code: IMI, ISA Dated: April 1, 2003 Received: April 3, 2003
Dear Mr. Berglund:
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
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Page 2 – Mr. Ronald E. Berglund
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N Mather
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number: K024307
Dermosonic Non-Invasive Subdermal Therapy System Device Name:
Indications for use include the following:
- a. Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains i.
- Relieves muscle spasms ii.
- Temporarily improves local blood circulation jii.
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy :
- Relief of pain i.
- Muscle spasms ii.
- iii. Joint contractures
- iv. NOT for the treatment of malignancies
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Manh Milkence of CDRH
00
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
(Division Sign-Off) Division of General Restorative Devices 510(k) Number:
(Per 21 CFR 801.109)
§ 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.