(62 days)
Not Found
No
The description focuses on electrical stimulation and user-controlled intensity levels, with no mention of AI or ML algorithms for data analysis, decision-making, or personalized treatment.
Yes
The device is indicated for the relief of nausea and vomiting, which are medical conditions, and achieves this through electrical stimulation, thus qualifying it as a therapeutic device.
No
The device is indicated for the relief of nausea and vomiting, indicating a therapeutic function rather than a diagnostic one. It applies electrical stimulation to nerves in the wrist to provide relief, not to detect or analyze conditions.
No
The device description explicitly states it is contained within a wristband and provides relief through electrical stimulation, indicating it is a hardware device with electrical components.
Based on the provided information, the ReliefBand® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ReliefBand® Mechanism: The ReliefBand® device works by applying electrical stimulation to the nerves in the wrist. This is a physical intervention applied to the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to relieve nausea and vomiting, which is a therapeutic or symptomatic relief, not a diagnostic process.
Therefore, the ReliefBand® device falls under the category of a therapeutic or symptomatic relief device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ReliefBand® Devices are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
Product codes
GZJ
Device Description
The ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are non-invasive devices which are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy. The devices are contained within a wristband, and provide relief through electrical stimulation of the nerves in the patient's wrist.
The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately 2 fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles.
The ReliefBand® device Model RB-xL family has a user display that incorporates five blinking LEDs which are used to identify the intensity level (5 discrete LEDs, one for each intensity level), so that the patient can easily select the desired stimulation. Selection of the intensity level is performed via a pushbutton located on the user display, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. A sixth blinking LED is used to display the low battery indicator.
The ReliefBand® device Model RB-xL family is powered by two 3V lithium batteries. The batteries are not user replaceable in the disposable device model RB-DL, but are user replaceable in the reusable device models RB-EL and RB-RL. The battery life for all models is specified to be 150 hours when used at setting 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the counter use
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)
The performance data indicate that the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are substantially equivalent to the predicate ReliefBand® Devices distributed under K982967 and K994387.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KOZO190
510(k) SUMMARY MAR 2 1 2002 Woodside Biomedical Inc. ReliefBand® Device Models RB-DL, RB-EL, and RB-RL
SUBMITTER INFORMATION
| A. | Company Name: | Woodside Biomedical, Inc. |
|---|---|---|
| B. | Company Address: | 1915 Aston Avenue |
| Carlsbad, CA 92008 | ||
| C. | Company Phone: | |
| Company Fax: | (760) 804-6900 | |
| (760) 804-6925 | ||
| D. | Contact Person: | Tom Grey |
| Vice-President of Product | ||
| Development | ||
| Woodside Biomedical, Inc. | ||
| E. | Date Summary Prepared: | January 16, 2002 |
DEVICE IDENTIFICATION
| A. | Classification Name: | Transcutaneous Nerve Stimulator |
|---|---|---|
| B. | Trade/Proprietary Name: | ReliefBand® Device |
| C. | Classification: | Class II (21 CFR 882.5890) |
| D. | Product Code: | GZJ |
IDENTIFICATION OF PREDICATE DEVICE
The Woodside Biomedical, Inc. ReliefBand® device Models RB-DL, RB-EL, and RB-RL are of comparable type and are substantially equivalent to the following predicate devices:
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1
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ReliefBand® Device | |||
| Models RB-2, RB-6, | |||
| and RB-R (OTC) | Woodside Biomedical, Inc. | K982967 | February 23, 1999 |
| ReliefBand® Device | |||
| Models WB-2L, | |||
| WB-6L, and WB-RL | |||
| (Rx) | Woodside Biomedical, Inc. | K994387 | March 16, 2000 |
DEVICE DESCRIPTION
The ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are non-invasive devices which are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy. The devices are contained within a wristband, and provide relief through electrical stimulation of the nerves in the patient's wrist.
The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately 2 fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles.
The ReliefBand® device Model RB-xL family has a user display that incorporates five blinking LEDs which are used to identify the intensity level (5 discrete LEDs, one for each intensity level), so that the patient can easily select the desired stimulation. Selection of the intensity level is performed via a pushbutton located on the user display, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. A sixth blinking LED is used to display the low battery indicator.
The ReliefBand® device Model RB-xL family is powered by two 3V lithium batteries. The batteries are not user replaceable in the disposable device model RB-DL, but are user
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2
replaceable in the reusable device models RB-EL and RB-RL. The battery life for all models is specified to be 150 hours when used at setting 3.
INDICATIONS FOR USE
The ReliefBand® Devices are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the ReliefBand® Device and the predicate device has been performed. The results of this comparison demonstrate that the ReliefBand® Device is equivalent to the marketed predicate device. The differences between the ReliefBand® Device Models RB-DL, and RB-RL and RB-RL and the predicate models are insignificant and do not affect the safety or effectiveness of the device.
PERFORMANCE DATA
The performance data indicate that the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are substantially equivalent to the predicate ReliefBand® Devices distributed under K982967 and K994387.
CONCLUSIONS
Woodside Biomedical, Inc. has demonstrated through its evaluation of the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2002
Woodside Biomedical,Inc. C/O Carol L. Patterson Patterson Consulting Group 21911 Erie Lane Lake Forest, California 92630
Re: K020180
Trade/Device Name: ReliefBand® Device Models RB-DL, RB-EL and RB-RL Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: January 17, 2002 Received: January 18, 2002
Dear Ms. Patterson:
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. Iisting 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
4
Page 2 – Ms. Carol L. Patterson
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelle (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) I mis lotter will and in your your finding of substantial equivalence of your device to a legally premation fouried.com "Theesults 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 11 you desire specific acrise for for in vitro diagnostic devices), please contact the Office of additionally 21 Of IC For at 659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-6639 Compliance at (301) 594-4639. Also, please note the your do roos, pitted, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on information on your responsibilities under the Act may be obtained from the Oinor gonetal intornational 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 yours,
Mark A. Millison
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
5
OTC INDICATIONS FOR USE
510(k) Number:
KO20180 (To Be Assigned By FDA)
Device Name:
ReliefBand® Device Models RB-DL, RB-EL, and RB-RL
Indications For Use:
The ReliefBand® device is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ OR Over-The-Counter Use $\boxed{\checkmark}$
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative
and Neurological Devices
Confidential K020180
510(k) Number __25 1-16-02