Bonine Acupressure Bands

K211823 · Wellspring Pharmaceutical Corporation · MVV · Sep 1, 2021 · NE

Device Facts

• Record ID: K211823
• Device Name: Bonine Acupressure Bands
• Applicant: Wellspring Pharmaceutical Corporation
• Product Code: MVV · NE
• Decision Date: Sep 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

Device Story

Acupressure device; fabric band with Velcro closure and polypropylene dome; worn on wrists; applies mechanical pressure to Nei-Kuan (P6) acupressure point; user-adjustable pressure (4.5 to 7.8 psi); OTC use; intended to reduce nausea symptoms; non-invasive; no clinical data.

Clinical Evidence

No clinical data. Bench testing only; compared contact pressure of subject device to predicate devices.

Technological Characteristics

Nylon fabric band with Velcro closure; polypropylene acupressure dome (0.52 in diameter, 0.26 in height); mechanical pressure application; adjustable pressure settings (4.5, 5.7, 7.8 psi); wrist-worn; non-powered; manual operation.

Indications for Use

Indicated for reduction of nausea symptoms in patients experiencing nausea due to travel/motion, pregnancy/morning sickness, chemotherapy, or post-procedure anesthesia.

Predicate Devices

• TumEase Acupressure Bracelets (K193374)
• Sea-Band (K033268)

Submission Summary (Full Text)

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September 1, 2021

WellSpring Pharmaceutical Corporation % Mikel Alberdi President Drug Device Consulting 13014 N. Dale Mabry Hwy., #326 Tampa, Florida 33618

Re: K211823

Trade/Device Name: Bonine Acupressure Bands Regulatory Class: Unclassified Product Code: MVV Dated: June 11, 2021 Received: June 14, 2021

Dear Mikel Alberdi:

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

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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 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,

Amber Ballard, PhD For 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) K211823

Device Name Bonine Acupressure Bands

Indications for Use (Describe)

Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

| 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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Bonine Acupressure Bands 510(k) Summary K211823

| Submission Sponsor: | WellSpring Pharmaceutical Corporation<br>5911 North Honore Avenue, Suite 211<br>Sarasota, FL 34243 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Mikel Alberdi<br>Drug Device Consulting<br>13014 N. Dale Mabry Hwy., #326<br>Tampa, FL 33618<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 11, 2021 |
| Trade Name: | Bonine Acupressure Bands |
| Common Name: | Acupressure Bands |
| Product Code: | MVV |
| Classification Regulation: | Unclassified |
| Classification Panel: | Neurology |
| Device Class: | Unclassified - Pre-Amendment |
| Predicate Device(s): | Primary Predicate:<br>TumEase Acupressure Bracelets<br>K193374<br>510(k) Holder: MumEase<br><br>Secondary Predicate:<br>Sea-Band<br>K033268<br>510(k) Holder: Sea-Band Ltd |

# 510(k) Summary - K211823

## Device Description:

Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.

## Indications for Use:

Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

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# Comparison to Predicate Devices:

| Trade Name | Bonine Acupressure<br>Bands | TumEase Acupressure<br>Bracelet<br>K193374 | Sea-Band<br>K033268 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MVV | MVV | MVV |
| Regulation<br>Number | Unclassified | Unclassified | Unclassified |
| Regulation<br>Name | Device, Acupressure | Device, Acupressure | Device, Acupressure |
| Indications for<br>Use | Bonine Acupressure<br>Bands are intended to<br>reduce symptoms of<br>nausea. Nausea may be<br>experienced due to<br>Travel/Motion,<br>Pregnancy/Morning<br>Sickness,<br>Chemotherapy, and<br>Anesthesia (post-<br>procedure). | The acupressure<br>bracelets are intended to<br>reduce symptoms of<br>nausea.<br>Nausea can be caused<br>by a variety of causes<br>some examples include<br>Travel/Motion,<br>Pregnancy/Morning<br>Sickness,<br>Chemotherapy and<br>Anesthesia (post-<br>procedure). | The Sea-Band Limited<br>"Sea-Band" is indicated<br>for the relief of nausea.<br>Nausea is a symptom<br>that may experienced<br>due to a variety of<br>causes, for example:<br>Travel/Motion<br>•<br>Pregnancy (Morning<br>Sickness)<br>•<br>Chemotherapy<br>•<br>Post Operative |
| Over-The-<br>Counter Use | Yes | Yes | Yes |
| How Supplied | Two bands per box | Two bracelets in a<br>plastic case | Supplied in pairs in a<br>plastic case |
| Band<br>Material | Nylon fabric with<br>Velcro closure | Cloth and Velcro<br>Strap | Not publicly available |
| Band<br>Dimension | 10.5 in x 1 in | 13 in long by 1 in wide | Not publicly available |
| Pressure Point<br>Button<br>Material | Polypropylene | Medical Grade Stainless<br>Steel (316) | Not publicly available |
| Pressure Point<br>Button<br>Dimension | Diameter: 0.52 in<br>Height: 0.26 in | Diameter: 0.48 in | Not publicly available |
| Contact<br>Pressure | Tight: 7.8 psi<br>Medium: 5.7 psi<br>Loose: 4.5 psi | Not publicly available. | Not publicly available |
| Where used | Wrist; Nei-Kuan or (P6)<br>acupressure point. | Wrist (over thin<br>fabric); Nei-Kuan or<br>(P6) acupressure point. | Wrist; Nei-Kuan or (P6)<br>acupressure point. |
| Device<br>Application | Worn on both wrists | Worn on both wrists | Worn on both wrists |

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Bonine Acupressure Bands 510(k) Summarv K211823

### Performance Testing - Nonclinical/Bench

The performance of Bonine Acupressure Bands was comparable to the predicate device and was able to provide a similar average contact pressure in the pressure point bench testing.

### Performance Testing - Clinical

Not applicable. No clinical testing was conducted.

#### Substantial Equivalence

Bonine Acupressure Bands have the same intended use and similar characteristics as the predicate devices. The information and data provided in this submission demonstrates that any differences in the technological characteristics or materials do not raise any new questions of safety or effectiveness.

Based on comparison of indications for use, technological features, and performance testing, the Bonine Acupressure Bands has been shown to be substantially equivalent to the legally marketed predicate devices. This device does not raise any new safety or effectiveness questions as compared to the predicate devices.