(56 days)
No
The device description focuses on electrical stimulation and user-controlled intensity levels, with no mention of AI or ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Reliefband® is a digital therapeutic device."
No
The device is indicated for treatment (relief of nausea, retching, and vomiting) and acts as an adjunct to antiemetic therapy. It does not mention any function for diagnosis.
No
The device description explicitly states it is contained within a wristband and provides electrical stimulation, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Reliefband's Function: The Reliefband operates by applying electrical stimulation to the wrist to alleviate nausea, retching, and vomiting. It does not involve the analysis of any biological specimens.
- Device Description: The description clearly states it's a "non-invasive device" that provides relief through "electrical stimulation of the nerves on the ventral side of the patient's wrist."
Therefore, the Reliefband falls under the category of a therapeutic device that interacts with the body externally, rather than an IVD that analyzes samples from within the body.
N/A
Intended Use / Indications for Use
Reliefband® is a digital therapeutic device indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, morning sickness associated with pregnancy, and chemotherapy. Reliefband® is also indicated as an adjunct to antiemetic therapy in reducing postoperative nausea.
Product codes
GZJ
Device Description
The ReliefBand® 1.5 is a non-invasive device that is indicated for the counter use in the relief of mild to moderate nausea, retching and vomiting associated with chemotherapy, motion sickness, mild to moderate nausea and vomiting associated with pregnancy, and as an adjunct to antiemetics in reducing mild to moderate postoperative nausea. This device was originally marketed under its predicate name of Reliefband RB-EL (K020180) when owned by Woodside Biomedical, Inc. The devices are technologically identical. The same contract manufacturer has made this device for decades.
Exactly like its predicate, the Reliefband 1.5 is contained within a wristband, and provides relief of nausea, retching and vomiting through electrical stimulation of the nerves on the ventral side of the patient's wrist. The device can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately two 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® 1.5 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventral or palmar (i.e., inside) surface of either or both wrists, approximately two fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles.
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)
The performance data indicate that the Relief anily is substantially equivalent to the predicate devices cleared to market via 510(k) #s: K994387 and K020180.
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
510(k) Summary K173233
| Contact: | Barbara J. Whitman
Regulatory Affairs Consultant
ReliefBand Technologies
220 Gibraltar Road
Suite 270
Horsham, PA 19044 USA
Phone: 908-763-5225
Email: whitmanregulatory@gmail.com
Web: www.reliefband.com | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Prepared: | September 27, 2017 | |
| Trade name: | ReliefBand® Device | |
| Common Name: | Nerve Stimulation Therapy Device | |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief
(21 CFR 882.5890) | |
| Product Code: | GZJ | |
| Device Classification: | Class II | |
| Manufacturer and
Distributor: | ReliefBand Technologies
220 Gibraltar Road
Suite 270
Horsham, PA 19044 USA | |
Predicate Devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| (PRIMARY PREDICATE) | |||
| ReliefBand® Device | |||
| Models RB-DL, RB-EL, | |||
| and RB-RL (OTC) | Woodside Biomedical, | ||
| Inc. | K020180 | March 21, 2002 | |
| ReliefBand® Device | |||
| Models WB-2L, WB-6L, | |||
| and WB-RL (Rx) | Woodside Biomedical, | ||
| Inc. | K994387 | March 16, 2000 |
1
Description of the Subject Device
The ReliefBand® 1.5 is a non-invasive device that is indicated for the counter use in the relief of mild to moderate nausea, retching and vomiting associated with chemotherapy, motion sickness, mild to moderate nausea and vomiting associated with pregnancy, and as an adjunct to antiemetics in reducing mild to moderate postoperative nausea. This device was originally marketed under its predicate name of Reliefband RB-EL (K020180) when owned by Woodside Biomedical, Inc. The devices are technologically identical. The same contract manufacturer has made this device for decades.
Exactly like its predicate, the Reliefband 1.5 is contained within a wristband, and provides relief of nausea, retching and vomiting through electrical stimulation of the nerves on the ventral side of the patient's wrist. The device can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately two 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® 1.5 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.
Indications For Use
Reliefband® is a digital therapeutic device indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, morning sickness associated with pregnancy, and chemotherapy. Reliefband® is also indicated as an adjunct to antiemetic therapy in reducing postoperative nausea.
Technical Characteristics
A comparison of the technological characteristics of the ReliefBand® 1.5 Device family and the predicate devices has been performed. The results of the comparison demonstrate that the ReliefBand® 1.5 is substantially equivalent to the marketed predicate devices. The differences between the ReliefBand® 1.5 and the predicate models are based solely on marketing changes and do not affect the safety or effectiveness of the device. The Reliefband® 1.5 is technologically identical to its previously cleared predicate device Reliefband® RB-EL. (Please see table below).
2
Technical Characteristics - Substantial Equivalency Table
| Performance
Characteristic | Rx Predicate Device (K994387) | OTC Predicate Device RB-xL (K020180) | K173233
OTC ReliefBand® 1.5 |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. The ReliefBand NST Device is
indicated as an adjunct to antiemetics in
reducing postoperative nausea (PON) | The ReliefBand Devices are indicated for
over the counter use in the relief of
nausea and vomiting (NV) due to motion
sickness and for relief of mild to
moderate nausea and vomiting
associated with pregnancy | Reliefband® is a digital therapeutic
device indicated for use in the treatment
of nausea, retching and vomiting due to
motion sickness, morning sickness
associated with pregnancy, and
chemotherapy. Reliefband® is also
indicated as an adjunct to antiemetic
therapy in reducing postoperative
nausea. |
| Size | Teardrop shape (approximately 1.5" by 2" by 0.45" thick enclosure) | | |
| Weight | Approximately 1.2 ounce (34 grams) | | |
| Operating
Temperature | 10°C to 45°C (50°F to 113°F) (±18% output tolerance at operating extremes) | | |
| User Controls | Single push button (membrane keypad) | | |
| User Displays | Five flashing LED setting indicators (green), 2 second flash period during normal operation | | |
| | One flashing low battery LED indicator (red), 4 second flash period alternating with setting LED when in Low Battery operation | | |
| Operating Modes | | OFF | |
| Performance
Characteristic | Rx Predicate Device (K994387) | OTC Predicate Device RB-xL (K020180) | K173233
OTC ReliefBand® 1.5 |
| Output Range
(Peak pulse current at
nominal, 500 ohm
load) | Five discrete levels between 10 mA (± 15%) – 40 mA (± 15%). | | |
| Output Waveform
Characteristics
(At nominal, 500 Ohm
load) | Asymmetric biphasic pulses.
Ramp up, constant and ramp down phases. | | |
| Maximum Charge
Delivered
(Setting 5, charge per
pulse at nominal, 500
ohm load) | Approximately 3.1 microcoulombs (max. 3.56 microcoulombs including 15% output tolerance) | | |
| Maximum Output
Voltage
(open circuit, no load) | 110 Volts | | |
| Output Channels | Two captive electrodes. | | |
| Regulation of
Stimulus Output with
Decreasing Battery
Voltage | Regulation is ± 5% of nominal output. Device stops stimulation when regulation cannot be maintained (device turns itself off). | | |
| Battery Life:
(Setting 3 at nominal) | 150 hours continuous or intermittent use when two 3V CR2025 used.
Low battery indicator flashes when approximately 10% of battery life remains. | | |
3
Performance Data
The performance data indicate that the Relief anily is substantially equivalent to the predicate devices cleared to market via 510(k) #s: K994387 and K020180.
4
Basis for Determination of Substantial Equivalence
Substantial equivalence was determined on the basis that there have been no changes in the mechanism of action, intended use and safety and effectiveness. The technology of the subject device has remained identical to that of its predicates and is therefore substantially equivalent to the predicate devices.
5
Image /page/5/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2017
ReliefBand Technologies % Barbara Whitman President Whitman Regulatory Consulting 616 Revere Court Flemington, New Jersey 08822
Re: K173233
Trade/Device Name: ReliefBand 1.5 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: September 27, 2017 Received: October 5, 2017
Dear Barbara Whitman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
6
Page 2 - Barbara Whitman
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
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