ReliefBand

K182960 · Reliefband Technologies, LLC · GZJ · Jun 21, 2019 · Neurology

Device Facts

• Record ID: K182960
• Device Name: ReliefBand
• Applicant: Reliefband Technologies, LLC
• Product Code: GZJ · Neurology
• Decision Date: Jun 21, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ReliefBand 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.

Device Story

Wrist-worn, rechargeable, non-invasive digital therapeutic device; provides transcutaneous electrical nerve stimulation (TENS) to the median nerve at the P6 wrist location. User operates device via pushbuttons to select pulse amplitude; intensity displayed via 10-segment linear LED; battery status via 4-segment circular LED. Device delivers asymmetric biphasic pulses at 31 Hz; constant current output. Used by patients in home or clinical settings for relief of mild to moderate nausea/vomiting. Output affects nerve signaling to mitigate nausea symptoms; provides non-pharmacological benefit.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence established through comparison of technological characteristics, performance specifications, and adherence to risk management standards (ISO 14971).

Technological Characteristics

Transcutaneous electrical nerve stimulator; asymmetric biphasic pulse waveform; 31 Hz frequency; 8-40 mA output range. Materials: 316L surgical grade stainless steel contacts, hypoallergenic latex-free band. Power: Rechargeable Li-Ion Polymer battery (IEC 62133 compliant). Connectivity: Standalone. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients experiencing nausea, retching, and vomiting due to motion sickness, chemotherapy, or pregnancy-related morning sickness. Also indicated as an adjunct to antiemetics for postoperative nausea.

Regulatory Classification

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.

Predicate Devices

• ReliefBand 1.5 (K173233)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

June 21, 2019

ReliefBand Technologies LLC Barbara Whitman Vice President, Regulatory Affairs and Quality Assurance 220 Gibraltar Road, Suite 270 Horsham, Pennsylvania 19044

Re: K182960

Trade/Device Name: 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: May 22, 2019 Received: May 22, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Pamela Scott 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) K182960

Device Name ReliefBand 2.0

Indications for Use (Describe)

ReliefBand 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.

| 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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## 510(k) SUMMARY K182960 ReliefBand 2.0

#### Submitter Information

Applicant: Relief band® Technologies LLC 220 Gibralter Road, Suite 270 Horsham, PA 19044 Phone: [phone] Ext 122 Contact: Barbara Whitman Vice President of Regulatory Affairs and Quality Assurance Date Prepared: October 15, 2018

## Device Classification

Trade name: 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 Device: ReliefBand® 1.5, K173233

#### Description of the Device

ReliefBand® 2.0 is a rechargeable, non-invasive digital therapeutic device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over the counter use in the relief of mild to moderate nausea 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.

ReliefBand 2.0® includes a hypoallergenic band with two electrical contacts on the clasp end of the band. The two contacts must be placed firmly against the underside of 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 in the wristband 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 incorporates a ten-segment linear LED that is used to display the intensity level. 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 edge of the device. Battery charge level is indicated by a separate four-segment circular LED. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.

## Indications for Use

ReliefBand® 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.

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## Technical Characteristics

A comparison of the technological characteristics of the ReliefBand® 2.0 and the predicate device ReliefBand® 1.5 has been performed. The results of the comparison demonstrate that the ReliefBand® 2.0 device is substantially equivalent to the marketed predicate device. The differences between the ReliefBand® and the predicate device do not raise new questions about the safety or effectiveness of the device.

## Basis for Determination of Substantial Equivalence

Substantial equivalence was determined on the basis that there have been no changes in the technology, mechanism of action or intended use. Device modifications include relocation of the electrodes from the back of the device face to the clasp end of the wrist band, changes in the size, shape and aesthetic appearance of the casing, a simpler and more streamlined user interface and a power source change from disposable to rechargeable batteries. There is a new user interface that provides 10 increments of intensity from 8 to 40 mA where there were previously 5 increments from 10 to 40 mA. These changes do not impact the safety of efficacy of the ReliefBand® 2.0 device.

| Item | ReliefBand 1.5 | ReliefBand 2.0 | Comments |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Reliefband® is a digital<br>therapeutic device<br>indicated for use in the<br>treatment of nausea,<br>retching and vomiting due<br>to motion sickness,<br>morning sickness<br>associated with pregnancy,<br>and chemotherapy.<br>Reliefband® is also<br>indicated as an adjunct to<br>antiemetic therapy in<br>reducing post-operative<br>nausea. | Reliefband® 2.0 is<br>indicated for use in the<br>treatment of nausea,<br>retching and vomiting<br>due to motion<br>sickness,<br>chemotherapy and<br>morning sickness<br>associated with<br>pregnancy.<br>Reliefband® 2.0 is<br>also indicated as an<br>adjunct to antiemetics<br>in reducing | Similar |
| Size | Teardrop shape, 3.81W x<br>5.08L x 1.14 H cm | Rectangular shape,<br>1.45 W x 2.35 L x 0.41<br>H cm | Does not affect<br>safety and<br>effectiveness |
| Weight | Approximately 34 grams | Approximately 50<br>grams | Does not affect<br>safety and<br>effectiveness |
| Operating<br>Temperature | 10°C to 45°C (50°F to<br>113°F) ±18% output<br>tolerance at operating<br>extremes | Same | Identical |
| User Controls | Push Button | Two Push Buttons:<br>On/Off and Intensity<br>Down/Up | Does not affect<br>safety and<br>effectiveness |
| Operating<br>Modes | OFF<br>ON/Set intensity level | Same | Identical |
| Interactive<br>Display | Five flashing LED setting<br>indicators (green), 2<br>second flash period during<br>normal operation. One<br>flashing low battery LED<br>indicator (red), 4 second<br>flash period alternating<br>with setting LED when in<br>Low Battery operation | Blue LED logo pulsing<br>means device is<br>providing therapy.<br>Ten diagonal blue<br>LED bars indicate<br>therapy power level.<br>Four circular blue<br>LED segments indicate<br>battery charge level. | Does not affect<br>safety and<br>effectiveness |
| Display Face<br>Location | Ventral side | Dorsal side | Does not affect<br>safety and<br>effectiveness |
| Output<br>Waveform | Asymmetric biphasic<br>pulses.<br>Ramp up, constant and<br>ramp down phases. | Same | Identical |
| Peak pulse<br>amplitude | Five discrete levels<br>between 10-40 mA<br>(nominal), set by intensity<br>selection; nominally<br>constant current, +/-10%<br>at nominal conditions | Ten discrete levels<br>between 8-40 mA<br>(nominal), set by<br>intensity selection;<br>nominally constant<br>current, +/-10% at<br>nominal conditions | Similar |
| Pulse<br>frequency | Fixed at 31 Hz (32<br>millisecond period). | Same | Identical |
| Amplitude<br>modulation<br>cycle | Single cycle | Same | Identical |
| Maximum<br>Charge<br>Delivered<br>(500 Ω2 load) | Approximately 3.1<br>microcoulombs (max. 3.56<br>microcoulombs including<br>15% output tolerance) | Same | Identical |
| Electrodes | Two gold-plated copper,<br>nickel or zinc | Two hypoallergenic<br>surgical grade (316L)<br>stainless steel contacts | Previously cleared<br>material. Does not<br>adversely impact<br>safety and/or<br>effectiveness |
| Device Status<br>Indicators | Five separate green<br>flashing LEDs indicate 5<br>intensity levels. Selection<br>of the intensity level is<br>performed via a<br>pushbutton located on the<br>user display. A sixth<br>blinking LED is used to<br>display the low battery<br>indicator. | Ten Intensity level<br>LEDS are arranged in<br>a single line. Selection<br>of the intensity level is<br>performed via a<br>pushbutton on the edge<br>of the face. Battery<br>charge indicator<br>provides 4 charge<br>levels and a red | Does not affect<br>safety and<br>effectiveness |
| Power | 3V, CR2025 Lithium coin<br>cells only, replaceable. | Rechargeable 40 mA<br>Li-Ion Polymer (max<br>capacity 50 mA) | Conforms to IEC<br>62133 standard. |
| Regulation of<br>Stimulus<br>output with<br>decreasing<br>battery<br>voltage | Regulation is ± 5% of<br>nominal output. Device<br>stops stimulation when<br>regulation cannot be<br>maintained (device turns<br>itself off). | Same | Identical |
| Battery life | 150 hours continuous or<br>intermittent use when<br>two 3V CR2025 used. | Approximately three<br>years or 500 charge<br>cycle | Does not adversely<br>impact safety<br>and/or<br>effectiveness |
| Low battery<br>warning | Low battery indicator<br>flashes when<br>approximately 10% of<br>battery life remains | When battery level<br>registers 15% or less, a<br>single LED segment<br>will switch from static<br>blue to flashing red | Does not adversely<br>impact safety<br>and/or<br>effectiveness |
| Wrist band | Contains latex | Latex free | Conforms to ISO<br>10993 standard |

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## Performance Specifications

The performance specifications for the ReliefBand® 2.0 device are substantially equivalent to the predicate device. ReliefBand 2.0 was tested to the following standard:

- ISO 14971: Medical Devices Application of Risk Management to Medical Devices -
## Conclusion:

A comparison of the technological characteristics of the ReliefBand® 2.0 and the predicate device ReliefBand® 1.5 was performed. The results of the comparison demonstrate that the ReliefBand® 2.0 device is substantially equivalent to the marketed predicate device.