(309 days)
Not Found
Not Found
No
The summary provides no indication of AI/ML technology. The intended use and device type (pain relief kit) are typical for non-AI/ML devices. There are no mentions of AI, ML, image processing, or data sets for training/testing.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
The device is intended for pain relief, not for diagnosing a condition or disease.
No
The summary describes a "Kit" intended for pain relief, which strongly suggests the inclusion of hardware components (e.g., electrodes, stimulator) in addition to any potential software. The lack of a device description prevents confirmation, but the term "Kit" is the primary indicator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain in the lower back. This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly points away from an IVD.
- Other Information: The lack of mentions of image processing, AI/ML, input imaging modality, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These elements are commonly associated with diagnostic devices, especially those involving analysis of biological samples or medical images.
This device appears to be a therapeutic device intended for pain relief.
N/A
Intended Use / Indications for Use
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Product codes
GZJ, GXY, IQE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 2003
Dan Jeffery Axelgaard Mfg. Co., Ltd. 1667 S. Mission Road Fallbrook, California 92028-4115
Re: K013532
Trade/Device Name: UltraStim Kit Regulation Number: 21 CFR 882.5890, 21 CFR 882.1320 and 21 CFR 890.3490 Regulation Name: Transcutaneous Electrical Nerve Stimulator, Cutaneous Electrode and Truncal Orthosis
Regulatory Class: Class II Product Code: GZJ, GXY and IQE Dated: May 28, 2002 Received: June 6, 2002
Dear Mr. Jeffery:
This letter corrects our substantially equivalent letter of August 22, 2002 to clarify the over-the-counter (OTC) status of your device.
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 (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 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.
1
Page 2 - Mr. Dan Jeffery
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.
This letter will allow you to continue 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Mark H. Mulkusa
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
510(k) Number (if known): K013532
Device Name: UltraStim Kit
Indications for Use:
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter (OTC) Use
l. Mark N. Millman
al, Restorative
510(k) N