(42 days)
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No
The summary describes a device that uses an inflatable garment to simulate massage techniques. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the mechanical action of the device.
Yes
The device is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation, which are therapeutic claims.
No
The device is described as providing temporary relief of muscle aches and pains and increasing circulation, which are therapeutic functions, not diagnostic ones that identify or characterize a disease or condition.
No
The device description explicitly states it uses an "inflatable garment," which is a hardware component.
Based on the provided information, the Air Press Massager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Air Press Massager is a physical therapy device that applies external pressure to the body. Its intended use is for temporary relief of muscle aches and pains and increasing circulation, which are physical effects, not diagnostic tests on biological samples.
The description clearly indicates a device that interacts with the external body through an inflatable garment, not one that analyzes biological specimens.
N/A
Intended Use / Indications for Use
The Air Press Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people with good health. The Air Press simulates kneading and stroking of tissues by using an inflatable garment.
Product codes
IRP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of a human figure with outstretched arms, symbolizing care and protection. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2003
Telebrands Corporation c/o Donald Segal Buchanan Ingersoll 1776 K St., N.W., Suite 800 Washington, DC 20006-2365
Re: K032505
Trade/Device Name: Telebrand Air Press Massager Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 13, 2003 Received: August 13, 2003
Dear Mr. Segal:
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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Page 2 - Mr. Donald E. Segal
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) 594-1308. 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
l. Mark N. Milken
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for TeleBrands. The logo is in black and white, with the word "TELE" in a bold, stylized font that is partially obscured by a black rectangle with rounded corners. The word "Brands" is written in a more standard font to the right of "TELE", and there is a registered trademark symbol to the right of "Brands".
Statement of Indications for Use
The Air Press Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people with good health. The Air Press simulates kneading and stroking of tissues by using an inflatable garment.
for Mark N Millikan
(Division Sign-Off) Division of General, Restorative and Neurological Devices KO3 2505
510(k) Number _