(86 days)
No
The description focuses on electrical stimulation and a single dial control, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a "non-invasive nerve stimulation therapy device" and is indicated for the "treatment of nausea and vomiting," directly stating its therapeutic purpose.
No
The device is described as a non-invasive nerve stimulation therapy device used for the treatment of nausea and vomiting, not for diagnosis.
No
The device description explicitly states that the device is contained within a wristband and provides relief through electrical stimulation, indicating a hardware component responsible for delivering the therapy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of nausea and vomiting. IVD devices are used for the diagnosis of diseases or conditions.
- Device Description: The device is a non-invasive nerve stimulation therapy device that provides relief through electrical stimulation. This is a therapeutic mechanism, not a diagnostic one.
- Mechanism of Action: The device works by stimulating nerves in the wrist, which is a physical intervention, not an in vitro test of biological samples.
The description clearly indicates a therapeutic device used for symptom relief, not a diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS).
Product codes
GZJ, BWK
Device Description
The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS). The devices are contained within a wristband, and provide relief of nausea and vomiting 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® NST™ Device Models WB-2, WB-6, and WB-R have a single dial for setting the stimulation , and incorporate an LED which is used to display a normal operating condition (green color at a slow flash rate) and a low battery condition (red color at a faster flash rate).
All three models have a single operating mode, controlled by a single dial, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. The three models vary by (1) the number of intensity settings available to the user, (2) whether or not the device is reusable, and (3) the length of time that the batteries will last. These features are summarized in Table 1:
| | WB-2
(2-Day, Disposable) | WB-6
(6-Day, Disposable) | WB-R
(Reusable) |
|-----------------------------------------------------------|-----------------------------|-----------------------------|--------------------|
| Identification of
discrete impulse
intensity levels | Level 1 | Level 1 | Level 1 |
| | | Level 1.5 | Level 1.5 |
| | Level 2 | Level 2 | Level 2 |
| | | Level 2.5 | Level 2.5 |
| | Level 3 | Level 3 | Level 3 |
The user dial on the WB-2, WB-6, and WB-R devices identifies the intensity level, so the patient can select the desired stimulation easily. All models are powered by two 3V lithium batteries. The batteries in Models WB-2 and WB-6 are not user replaceable. The batteries in Model WB-R are user replaceable and are commercially available. Battery life for the three models is as follows:
- Model WB-2: approximately 2 days (48 hours) on level 2; batteries not replaceable. ●
- Model WB-6: approximately 6 days (144 hours) on level 2; batteries not replaceable. .
- Model WB-R: approximately 6 days (144 hours) on level 2 before the batteries need . to be replaced.
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
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)
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
SUMMARY OF SAFETY AND EFFECTIVENESS Woodside Biomedical Inc. ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R
SUBMITTER INFORMATION
| A. | Company Name: | Woodside Biomedical, Inc. |
|---|---|---|
| B. | Company Address: | 1915 Aston Avenue, Suite 102 |
| Carlsbad, CA 92008 | ||
| C. | Company Phone: | (760) 804-6900 |
| Company Fax: (760) 804-6925 | ||
| D. | Contact Person: | Tom Grey |
| Vice-President of Product | ||
| Development | ||
| Woodside Biomedical, Inc. | ||
| E. | Date Summary Prepared: | July 7, 1998 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Nerve Stimulation Therapy Device |
|---|---|---|
| B. | Trade/Proprietary Name: | ReliefBand® NST™ (Nerve Stimulation |
| Therapy) Device | ||
| C. | Classification: | Class II |
| D. | Product Code: | GZJ and BWK |
IDENTIFICATION OF PREDICATE DEVICE
| Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ReliefBand, | |||
| Model SW-111 | Woodside Biomedical, Inc. | K980333 | February 18, 1998 |
172
1
DEVICE DESCRIPTION
The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS). The devices are contained within a wristband, and provide relief of nausea and vomiting 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® NST™ Device Models WB-2, WB-6, and WB-R have a single dial for setting the stimulation , and incorporate an LED which is used to display a normal operating condition (green color at a slow flash rate) and a low battery condition (red color at a faster flash rate).
All three models have a single operating mode, controlled by a single dial, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. The three models vary by (1) the number of intensity settings available to the user, (2) whether or not the device is reusable, and (3) the length of time that the batteries will last. These features are summarized in Table 1:
| | WB-2
(2-Day, Disposable) | WB-6
(6-Day, Disposable) | WB-R
(Reusable) |
|-----------------------------------------------------------|-----------------------------|-----------------------------|--------------------|
| Identification of
discrete impulse
intensity levels | Level 1 | Level 1 | Level 1 |
| | | Level 1.5 | Level 1.5 |
| | Level 2 | Level 2 | Level 2 |
| | | Level 2.5 | Level 2.5 |
| | Level 3 | Level 3 | Level 3 |
TABLE 1
2
The user dial on the WB-2, WB-6, and WB-R devices identifies the intensity level, so the patient can select the desired stimulation easily. All models are powered by two 3V lithium batteries. The batteries in Models WB-2 and WB-6 are not user replaceable. The batteries in Model WB-R are user replaceable and are commercially available. Battery life for the three models is as follows:
- Model WB-2: approximately 2 days (48 hours) on level 2; batteries not replaceable. ●
- Model WB-6: approximately 6 days (144 hours) on level 2; batteries not replaceable. .
- Model WB-R: approximately 6 days (144 hours) on level 2 before the batteries need . to be replaced.
SUBSTANTIAL EQUIVALENCE
The Woodside Biomedical, Inc. ReliefBand® NST™ devices, Models WB-2, WB-6, and WB-R devices are of comparable type and are substantially equivalent to the predicate ReliefBand®, Model SW-111 (K980333).
INDICATION FOR USE
The ReliefBand NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS).
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the ReliefBand® NST™ Device and the predicate device has been performed. The results of this comparison demonstrate that the ReliefBand® NST™ Device is equivalent to the marketed predicate device.
174
3
PERFORMANCE DATA
The performance data indicate that the ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are substantially equivalent to the ReliefBand® Devices distributed under K980333.
175
4
Image /page/4/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.
8 1998 OCT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol L. Patterson Patterson Consulting Group Consultant for Woodside Biomedical, Inc. 18140 Smokesignal Drive San Diego, California 92127
Re: K982436 Trade Name: ReliefBand® NST™ Device Models WB-2, WB-6, WB-R Regulatory Class: II Product Codes: GZJ and BWK Dated: July 13, 1998 Received: July 14, 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 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements 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.
5
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 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" (21 CFR 807.97). 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
6
INDICATIONS FOR USE
510(k) Number: K982436
Devicc Name:
- P
ReliefBand® NST™ Device Models WB-2. WB-6, and WB-R
Indications For Use:
The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of General Restorative Devices K982436
510(k) Number
Prescription Use (Pcr 21 CFR 801.109)
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Over The-Counter Use .........................................................................................................................................................