(322 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use for pain and swelling relief.
Yes
The device is intended to provide temporary relief from various medical symptoms such as aches, pains, swelling, and lymphoedema, which are direct therapeutic benefits.
No
The device provides temporary relief from symptoms like aches, pains, and swelling; it does not diagnose a medical condition.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. Without this information, it's impossible to assess the nature of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes providing temporary relief from physical symptoms like aches, pains, swelling, and lymphoedema. This is a therapeutic or symptomatic relief function, not a diagnostic one.
- Lack of Diagnostic Activity: IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such activity or the analysis of biological samples.
- Device Description (Not Found): While the device description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information about image processing, AI/ML, imaging modality, anatomical site, patient age range, training/test sets, performance studies, and key metrics further supports that this is not a diagnostic device. These elements are often relevant for diagnostic devices, especially those involving imaging or data analysis.
In summary, the intended use clearly points to a device that provides physical relief, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
By individuals or clinicians, to provide temporary relief from localized aches, pains and / Dy in widdlers of calvisions, to provises caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.
Product codes
IRP
Device Description
Not Found
Mentions image processing
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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
individuals or clinicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which features three horizontal lines that resemble a bird in flight, positioned above a wavy line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2005
Tohkai Precision Mfy, Ltd. C/o Robert T. Wagner President AEGIS. Inc. 2840 Scherer Drive North Saint Petersburg, Florida 33716
Re: K040905
Trade/Device Name: Wellness/ Jolivette Massage Booties Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP Dated: February 14, 2005 Received: February 14, 2005
Dear Mr. Wagner:
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 (sec 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 53 1-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Mr. Wagner
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 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
2
Indications for Use
Wellness / Jolivette Massage Booties (Tohkai Precision Mfy, Itd., Hong Kong)
Indications for Use:
By individuals or clinicians, to provide temporary relief from localized aches, pains and / Dy in widdlers of calvisions, to provises caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.
Prescription Use (21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K640905