(79 days)
Not Found
No
The device description focuses on electrical stimulation and user-controlled intensity, with no mention of AI or ML technologies.
Yes.
The device description explicitly states, "ReliefBand® models 1.5 and 2.0 are battery-powered non-invasive digital therapeutic devices."
No
The ReliefBand is a therapeutic device that provides electrical stimulation to relieve nausea and vomiting. It does not diagnose conditions.
No
The device description explicitly states it is a "battery-powered non-invasive digital therapeutic device" with "two electrical contacts" and a "user display that includes a five-level (ReliefBand 1.5) or 10-level (ReliefBand 2.0) LED". These are all hardware components.
Based on the provided information, this 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.
- Device Function: The ReliefBand device works by applying electrical stimulation to the wrist to alleviate nausea and vomiting. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is for the treatment of symptoms (nausea and vomiting), not for diagnosing a condition.
The device is a therapeutic device that provides electrical stimulation.
N/A
Intended Use / Indications for Use
ReliefBand(R) is indicated for use in the treatment of nausea, vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.
Product codes
GZJ
Device Description
ReliefBand(R) models 1.5 and 2.0 are battery-powered non-invasive digital therapeutic devices that are worn on the wrist like a watch. They are indicated for the counter use in the relief of mild to moderate nausea and retching associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness associated with pregnancy as an adjunct to antiemetics in reducing mild to moderate postoperative nausea.
ReliefBand 1.5 and 2.0 include two electrical contacts on the back of the device (ReliefBand 1.5) or on the clasp (ReliefBand 2.0), which must be placed firmly against the underside of the wrist at the P6 location (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 electrodes provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
The ReliefBand device has a user display that includes a five-level (ReliefBand 1.5) or 10-level (ReliefBand 2.0) LED that indicates the signal intensity. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton located on the face of the devices. A low battery indicator LED is also included on the face of the devices. ReliefBand 1.5 uses disposable batteries while ReliefBand 2.0 has a lithium-ion rechargeable battery. A fully charged battery will last for up to 18 hours of continuous use at the mid-power level or below.
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)
Not Found
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).
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August 30, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ReliefBand Technologies LLC Barbara Whitman Vice President, Regulatory Affairs and Quality Assurance 220 Gibraltar Rd Ste 270 Horsham, Pennsylvania 19044
Re: K191547
Trade/Device Name: ReliefBand 1.5 and ReliefBand 2.0 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: July 30, 2019 Received: August 1, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang, PharmD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191547
Device Name ReliefBand 1.5 and ReliefBand 2.0
Indications for Use (Describe)
ReliefBand(R) is indicated for use in the treatment of nausea, vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary K191547
Submitter Information
Applicant: Reliefband® Technologies LLC 220 Gibralter Road, Suite 270 Horsham, PA 19044
Phone: 877-735-2263 Ext 122
Contact: Barbara Whitman
Vice President of Regulatory Affairs and Quality Assurance
Date Prepared: July 30, 2019
Device Classification Trade name: ReliefBand® 1.5, ReliefBand® 2.0
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
Predicate Devices: ReliefBand® 1.5 (K173233) and ReliefBand® 2.0 (K182960)
Description of the Device
ReliefBand® models 1.5 and 2.0 are battery-powered non-invasive digital therapeutic devices that are worn on the wrist like a watch. They are indicated for the counter use in the relief of mild to moderate nausea and retching associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness associated with pregnancy as an adjunct to antiemetics in reducing mild to moderate postoperative nausea.
ReliefBand 1.5 and 2.0 include two electrical contacts on the back of the device (ReliefBand 1.5) or on the clasp (ReliefBand 2.0), which must be placed firmly against the underside of the wrist at the P6 location (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 electrodes provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
The ReliefBand device has a user display that includes a five-level (ReliefBand 1.5) or 10-level (ReliefBand 2.0) LED that indicates the signal intensity. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton
4
located on the face of the devices. A low battery indicator LED is also included on the face of the devices. ReliefBand 1.5 uses disposable batteries while ReliefBand 2.0 has a lithium-ion rechargeable battery. A fully charged battery will last for up to 18 hours of continuous use at the mid-power level or below.
Indications for Use
ReliefBand is indicated for use in the treatment of nausea, vomiting and retching associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.
Technical Characteristics
The subject and the predicate ReliefBand devices are identical. Only the wording in the indications for use has changed. The are no changes in technical characteristic between the predicate and the subject devices. The differences between the subject ReliefBand and the predicate device do not raise new questions about the safety or effectiveness of the device.
| Item | ReliefBand® 1.5 and 2.0 (Predicate Devices) | ReliefBand® 1.5 and 2.0 (Subject Devices) |
|---|---|---|
| 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. | |
| Relief Band 2.0 is indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, chemotherapy and morning sickness associated with pregnancy. ReliefBand 2.0 is also indicated as an adjunct to antiemetics in reducing postoperative nausea. | Reliefband® is indicated for use in the treatment of nausea, vomiting and retching associated with physician diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use. | |
| Size | ||
| ReliefBand 1.5 | Teardrop shape, 3.81Wx5.08Lx1.14H cm | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Rectangular shape, 1.45Wx2.35Lx0.41H cm | Identical for ReliefBand 2.0 |
| Weight | ||
| ReliefBand 1.5 | Approximately 34 grams | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Approximately 50 grams | Identical for ReliefBand 2.0 |
| Operating | ||
| Temperature | ||
| ReliefBand 1.5 | 10°C to 45°C (50°F to 113°F) ±18% output tolerance at operating extremes | Identical |
| ReliefBand 2.0 | ||
| User Controls | ||
| ReliefBand 1.5 | One Push Button: On/Off/Intensity | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Two Push Buttons: On/Off (1), Intensity (2) | Identical for ReliefBand 2.0 |
| Operating Modes | ON/OFF/Set intensity level | Identical |
| ReliefBand 1.5 | 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. | Identical for Relief Band 1.5 | |
| ReliefBand 2.0 | Ten diagonal blue LED bars indicate therapy | |
| power level. Four circular blue LED segments | ||
| indicate battery charge level. | Identical for ReliefBand 2.0 | |
| Display Face | ||
| Location | ||
| ReliefBand 1.5 | Ventral side | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Dorsal Side | Identical for ReliefBand 2.0 |
| Output Waveform | Asymmetric biphasic pulses. | |
| Ramp up, constant and ramp down phases. | Identical | |
| Peak pulse | ||
| Amplitude | ||
| ReliefBand 1.5 | Five discrete levels between 10-40 mA (nominal), | |
| set by intensity selection; nominally constant | ||
| current, +/-10% at nominal conditions | Identical for ReliefBand 1.5 | |
| ReliefBand 2.0 | Ten discrete levels between 8-40 mA (nominal), | |
| set by intensity selection; nominally constant | ||
| current, +/-10% at nominal conditions | Identical for ReliefBand 2.0 | |
| Pulse frequency | Fixed at 31 Hz (32 millisecond period). | Identical |
| Pulse width | Fixed at 350 milliseconds. | Identical |
| Amplitude | ||
| modulation cycle | Single cycle | Identical |
| Maximum Charge | ||
| Delivered (500 Ω | ||
| load) | Approximately 3.1 microcoulombs (max. 3.56 | |
| microcoulombs including 15% output tolerance) | Identical | |
| Electrodes | ||
| ReliefBand 1.5 | Two gold-plated copper, nickel or zinc | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Two hypoallergenic surgical grade (316L) | |
| stainless steel contacts | Identical for ReliefBand 2.0 | |
| Device Status | ||
| Indicators | ||
| ReliefBand 1.5 | Five separate green flashing LEDs indicate 5 | |
| intensity levels. Selection of the intensity level is | ||
| performed via a pushbutton located on the user | ||
| display. A sixth blinking LED is used to display | ||
| the low battery indicator. | Identical for ReliefBand 1.5 | |
| ReliefBand 2.0 | Ten Intensity level LEDS are arranged in a single | |
| line. Selection of the intensity level is performed | ||
| via a pushbutton on the edge of the face. Battery | ||
| charge indicator provides 4 charge levels and a | ||
| red blinking low power warning LED. | Identical for ReliefBand 2.0 | |
| Power | ||
| ReliefBand 1.5 | 3V, CR2025 Lithium-ion coin cells only, replaceable. | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Rechargeable 40 mA Li-Ion Polymer - IEC62133 standard. Not replaceable. | Identical for ReliefBand 2.0 |
| Regulation of | ||
| Stimulus Output | ||
| with Decreasing | ||
| Battery Voltage | ||
| Battery Life | Regulation is ± 5% of nominal output. Device stops stimulation when regulation cannot be maintained (device turns itself off). | Identical |
| ReliefBand 1.5 | 18 hours continuous or intermittent use with two 3V CR2025 | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | Approximately three years/ 500 charge cycles. | Identical for ReliefBand 2.0 |
| Low Battery | ||
| Warning | ||
| ReliefBand 1.5 | Low battery indicator flashes when approximately 10% of battery life remains. | Identical for ReliefBand 1.5 |
| ReliefBand 2.0 | When battery level registers 15% or less, a single LED segment will switch from static blue to flashing red. | Identical for ReliefBand 2.0 |
| Wrist Band | ||
| ReliefBand 1.5 | ||
| ReliefBand 2.0 | Contains latex | |
| Latex-Free | Identical for ReliefBand 1.5 | |
| Identical for ReliefBand 2.0 |
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Performance Specifications
The performance specifications for the applicant ReliefBand devices are identical, and thus substantially equivalent, to the predicate devices.
Basis for Determination of Substantial Equivalence
Substantial equivalence was determined on the basis that there have been no changes in the physical device, technology, mechanism of action or intended use. Device modifications include only the clarified intended use, which includes an additional anticipated source of nausea (physician-diagnosed migraine) that Reliefband is intended to treat. These changes do not impact the safety of efficacy of the ReliefBand 1.5 or ReliefBand 2.0 devices.