Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip

• K Number: K142471
• Device Name: Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
• Manufacturer: Pressure Point Inc.
• Date Cleared: 2014-12-01 ( 89 days)
• Product Code: MVV
• Regulation Number: N/A

Intended Use

Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

Device Description

The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point. The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

Predicate Devices

K110563, K033268

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical pressure application and do not mention any computational or learning components.

Therapeutic

Yes.
The device is used to relieve symptoms of nausea associated with various conditions, which is a therapeutic purpose.

Diagnostic

No

The device is described as providing relief from nausea symptoms by exerting pressure on an acupuncture point, not by diagnosing any condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "single-use, disposable acupressure strip" with a "hard plastic button," indicating it is a physical hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Pressure Right® 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 about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
• Pressure Right Function: The Pressure Right device is an externally applied acupressure strip that exerts pressure on a specific point on the wrist. It does not involve the analysis of any biological specimens from the body. Its mechanism of action is physical pressure, not a diagnostic test performed on a sample.

The description clearly states it's a "drug-free, Single-Use, Pressure Wrist Strip, externally applied" and its function is to provide "pressure stimulation effect to the P6 acupressure point". This aligns with a physical therapy or complementary medicine approach, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

Product codes

MVV

Device Description

The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wrist, on Nei-Kuan or (P6) acupressure point.

Indicated Patient Age Range

Adults, 18 years and older

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)

The following testing has been performed to support substantial equivalence:

• Bench testing to evaluate the psi pressure performance of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device to determine pressure equivalence.

The Pressure Right device meets all the requirements for overall design, biocompatibility, and has been confirmed that the output meets the design inputs and specifications. The Pressure Right device passed the testing stated above as shown by the acceptable results obtained.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K110563, K033268

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized design of an eagle or bird-like figure with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2014

Pressure Point Inc. c/o Julie Powell, Vice President Quality Assurance Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K142471

Trade/Device Name: Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip

Regulatory Class: Unclassified Product Code: MVV Dated: September 2, 2014 Received: September 3, 2014

Dear Ms. Julie Powell:

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. Isting 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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K142471

Device Name

Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (Pressure Right)

Indications for Use (Describe)

Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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510(k) Summary

for

Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist

1. Submission Sponsor

Pressure Point Inc. 36 Green Meadow Drive Tinton Falls, NJ 07724 USA Contact: Joseph DiLustro, CEO Phone: [phone]

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: [phone] Fax: [phone] Contact: Julie Powell, VP, QA Email: [e-mail]

3. Date Prepared

September 2, 2014

4. Device Identification

Trade/Proprietary Name: Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (Pressure Right)

Common/Usual Name:	Pressure Band, Acupressure Device
Classification Name:	Unclassified - Device, Acupressure
Classification Regulation:	NA
Product Code:	MVV
Device Class:	U (unclassified)
Classification Panel:	Neurology

5. Legally Marketed Predicate Device(s)

Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip Manufactured by Pressure Point, Inc. 510(k) K110563

Sea-Band® Manufactured by Sea-Band UK LTD. 510(k) K033268

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6. Device Description

The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

7. Indication for Use Statement

Pressure Right® is a drug-free, Single-Use, Pressure-Sensitive Acupressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion. For Over-the-Counter (OTC) use.

8. Substantial Equivalence Discussion

The following table compares the Pressure Right OTC device to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Pressure Point, Inc.	Pressure Point, Inc.	Sea-Band UK Ltd.
Trade Name	Pressure Right	Pressure Right	Sea-Band
510(k)
Number	Unknown	K110563	K033268
Product Code	MVV	MVV	MVV
Regulation
Number	Unclassified	Unclassified	Unclassified
Regulation
Name	Device, Acupressure	Device, Acupressure	Device, Acupressure
Indications for
Use	Pressure Right® is a drug-free, Single-Use, Pressure-Sensitive Acupressure
Wrist Strip, externally
applied, which is indicated
for relief of nausea
symptoms associated with
chemotherapy, post-
operative, pregnancy
(morning sickness) and
travel/motion.	Pressure Right®, Single-
Use, Disposable, Pressure-
Sensitive Emetic-
Management Wrist Strip is
indicated for the relief of
emetic (nausea and
vomiting) symptoms
associated with Post-
Operative Anesthesia.

Prescription Use | The Sea-Band Limited
"Sea-Band" is indicated
for the relief of nausea.
Nausea is a symptom
that may experienced
due to a variety of
causes, for example:
• Travel/Motion
• Pregnancy (Morning
Sickness)
• Chemotherapy
• Post Operative |
| Manufacturer | Pressure Point, Inc. | Pressure Point, Inc. | Sea-Band UK Ltd. |
| Trade Name | Pressure Right | Pressure Right | Sea-Band |
| | Over-The-Counter Use | | Over-The-Counter Use |
| How Supplied | Pressure Right is supplied
with 2 perforated Wrist
Strips in a sealed pouch
with instructions for use.
Pressure Right device also
comes with a unique P6
locator template to aid in
determining an individual's
P6 pressure point. | Pressure Right is supplied
with 2 perforated Wrist
Strips in a sealed pouch
with instructions for use.
Pressure Right device also
comes with a unique P6
locator template to aid in
determining an individual's
P6 pressure point. | Sea-Band supplied in
pairs in a plastic case. |
| Wrist Strip
Material | 3M™ Transpore Surgical
Tape
Manufactured from a low-
density perforated
polyethylene film with a
hypoallergenic, pressure-
sensitive, acrylate adhesive. | 3M™ Transpore Surgical
Tape
Manufactured from a low-
density perforated
polyethylene film with a
hypoallergenic, pressure-
sensitive, acrylate adhesive. | Elasticated wrist band -
specific material
unknown |
| Wrist Strip
Dimension | 5.50" long X 1.00" wide | 5.50" long X 1.00" wide | Unknown, various sizes |
| Pressure Point
Button
Material | Acrylonitrile butadiene
styrene (Lustran ABS 348),
Medical Grade | Acrylonitrile butadiene
styrene (Lustran ABS 348),
Medical Grade | Hard Plastic |
| Pressure Point
Button
Dimension | 0.52″ diameter x 0.27″ high | 0.52″ diameter x 0.27″ high | 0.52″ diameter x 0.27″
high |
| Typical
Contact
Pressure | 5-7 lbs/sq. in | 5-7 lbs/sq. in | 5-7 lbs/sq. in |
| Where used | Wrist, on Nei-Kuan or (P6)
acupressure point. | Wrist, on Nei-Kuan or (P6)
acupressure point. | Wrist, on Nei-Kuan or
(P6) acupressure point. |
| Device
Application | Worn on both wrists, via
Pressure sensitive tape /
adhesive. | Worn on both wrists, via
Pressure sensitive tape /
adhesive | Worn on both wrist, via
elastic band |
| Target
Population | Adults, 18 years and older | Adults, 18 years and older | Adults and Children age
two and up |

Table 5A - Device Comparison Chart: Similarities and Differences

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9. Non-Clinical Performance Data

Summary of Non-Clinical Data Submitted

The following testing has been performed to support substantial equivalence:

• . Bench testing to evaluate the psi pressure performance of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device to determine pressure equivalence.

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As part of demonstrating safety and effectiveness of Pressure Right device and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Pressure Point completed a number of tests. The Pressure Right device meets all the requirements for overall design, biocompatibility, and has been confirmed that the output meets the design inputs and specifications. The Pressure Right device passed the testing stated above as shown by the acceptable results obtained.

10. Clinical Performance Data

There was no new clinical testing required to support the medical device as bench testing was performed to evaluate the pressure equivalence of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device. These results were comparable and support the expanded indications of the Pressure Right device.

The predicate device, Pressure Right was clinically tested and the clinical data included in the predicate submission K110563. The predicate Pressure Right device has been on the market for several years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Pressure Right OTC device has the same indications for use, including OTC use as the predicate Sea-Band device. The Pressure Right OTC device prescription has identical technological characteristics as the Pressure Right predicate device. The new device does not raise different questions regarding its safety and effectiveness as compared to the predicate devices.