(182 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and intended use are purely focused on a non-AI/ML mechanism for nausea relief.
Yes
The device is indicated for the "relief of nausea and vomiting," which describes a therapeutic purpose.
No
The device is indicated for the "relief of nausea and vomiting," which describes a therapeutic or symptomatic relief function, not a diagnostic one. It does not mention identifying, analyzing, or characterizing a disease or condition.
No
The device description explicitly mentions "ReliefBand® Device Models RB-2, RB-6, and RB-R," implying physical hardware components. The intended use also describes a "Device" which is typically a physical entity.
Based on the provided information, the ReliefBand® Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of nausea and vomiting due to motion sickness. This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Device Description: The description refers to a "Device" and models, suggesting an external, non-invasive device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The ReliefBand® Device, as described, appears to be a non-invasive device that likely uses some form of stimulation (though the mechanism isn't detailed here) to alleviate symptoms.
N/A
Intended Use / Indications for Use
The ReliefBand® Device is indicated for the relief of nausea and vomiting (NV) due to motion sickness
Product codes
GZJ
Device Description
Not Found
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)
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).
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a flowing ribbon.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1999
Ms. Carol L. Patterson Consultant for Woodside Biomedical, Inc. Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127
Re: K982967 ReliefBand® NST™ Device, Trade Name: Models RB-2, RB-6, and RB-R Regulatory Class: II Product Code: GZJ November 24, 1998 Dated: Received: November 25, 1998
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Carol L. Patterson
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
WOODSIDE BIOMEDICAI., INC. RELIEFBAND® DEVICE OTC 510K
OTC INDICATIONS FOR USE
| 510(k) Number: | K982967
(To Be Assigned By FDA) |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Device Name: | ReliefBand® Device Models RB-2, RB-6, and
RB-R |
| Indications For Use: | The ReliefBand® Device is indicated for the relief of
nausea and vomiting (NV) due to motion sickness |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K982967 |
OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)