PSI BANDS

• K Number: K070766
• Device Name: PSI BANDS
• Manufacturer: PSI HEALTH SOLUTIONS, INC.
• Date Cleared: 2007-07-26 ( 128 days)
• Product Code: MVV
• Regulation Number: N/A

Intended Use

Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: - pregnancy (morning sickness) - motion sickness - anesthesia - chemotherapy. Psi Bands are intended for over-the-counter use.

Device Description

Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened. Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment. Components of the system include: Strap and collar made of medical grade Santoprene™ thermoplastic rubber Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap

Predicate Devices

K053509

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a mechanical acupressure wrist band with adjustable pressure settings. There is no mention of software, data processing, or any technology that would involve AI or ML. The performance studies are based on bench testing of physical properties.

Therapeutic

Yes
The device is intended for the relief of nausea, which is a symptom of various medical conditions, positioning it as a therapeutic aid.

Diagnostic

No

The device is indicated for the relief of nausea, which is a symptom, and does not perform any diagnostic function to identify, characterize, or monitor a disease or condition. It is a therapeutic device that applies pressure to an acupressure point.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of plastic and rubber that apply pressure, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Psi Bands Function: Psi Bands are described as acupressure wrist bands that apply pressure to a specific point on the wrist (Nei-kuan or P6) to relieve nausea. They do not involve testing any samples from the body.
• Intended Use: The intended use is for the relief of nausea, a symptom, by applying physical pressure. This is a mechanical or physical intervention, not a diagnostic test.
• Device Description: The description details the physical components and how they apply pressure. There is no mention of reagents, testing procedures, or analysis of biological samples.

Therefore, Psi Bands fall under the category of a physical or mechanical medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example:

• Pregnancy (morning sickness)
• Motion sickness
• Anesthesia
• Chemotherapy

Psi Bands are intended for over-the-counter use.

Product codes (comma separated list FDA assigned to the subject device)

MVV

Device Description

Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened.

Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment. Cytotoxicity, primary skin irritation, and sensitization testing of Santoprene™was performed by the manufacturer in accordance and compliance with Internal Organization for Standardization 10993 (See Biocompatibility Section). A Material Safety Data Sheet for the ABS plastic used in the button is attached (See Biocompatibility Section)

Psi Bands are offered in a variety of different colors and pack types.

Components of the system include:

Strap and collar made of medical grade Santoprene™ thermoplastic rubber Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap (See Device Description Section)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nei-kuan (P6) acupressure point on the 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)

The performance outputs of the Psi Band and the predicate device, i.e., contact area and pressure exerted on the P6 (Nei-guan) pressure point were compared by bench testing.

Conclusions: The performance outputs of the subject device and the predicate device are equivalent.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K053509

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image shows the text "PsiBands" in a stylized font. The letters are composed of small dots, giving the text a textured appearance. The overall impression is a logo or brand name.

noother bessites correlige : In you Pat - Josehin Schutinny

510(k) Summary

JUL 26 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 21 CFR $807.92.

510(k) number: K070766

1. Submitter's Identification:

Psi Health Solutions, Inc. 606 Lighthouse Avenue, #168 Pacific Grove, CA 93950 Contact: Romy Taormina Co-Founder/Treasurer/Secretary Date Summary Prepared:

2. Name of the Device:

Psi Band

3. Predicate Device Information:

Acuband Acupressure Wrist Band Device Acuband Inc. 101 Little Silver Point Road Little Silver, Nj 07739 510(k) number: K053509

4. Device Description:

Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened.

Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment. Cytotoxicity, primary skin irritation, and sensitization testing of

Image /page/0/Picture/15 description: The image contains three icons in a row. The first icon appears to be a person-like figure. The second icon appears to be a calendar. The third icon appears to be a plus sign.

e06 Lighthouse Ave. #168 · Parific Grove, Phone: [phone] - Fax: [phone] - www.bsibands.com

1

Image /page/1/Picture/0 description: The image shows the logo for PsiBands. The logo is in a sans-serif font and is in all lowercase letters. Below the logo is the text "Another healthy production from Psi Health Solutions, Inc.". The text is in a smaller font than the logo.

Santoprene™was performed by the manufacturer in accordance and compliance with Internal Organization for Standardization 10993 (See Biocompatibility Section). A Material Safety Data Sheet for the ABS plastic used in the button is attached (See Biocompatibility Section)

Psi Bands are offered in a variety of different colors and pack types.

Components of the system include:

Strap and collar made of medical grade Santoprene™ thermoplastic rubber Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap (See Device Description Section)

5. Intended Use:

Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example:

• pregnancy (morning sickness) �
• motion sickness .
• � anesthesia
• chemotherapy. .

Psi Bands are intended for over-the-counter use

The publications supporting the use of Psi Bands for relief of nausea resulting from the four causative factors listed above were cited and their conclusions discussed in the Substantial Equivalence Section. These references therefore support the indications for use claimed for PsiBands.

AccuBand wrist bands, the predicate device, are claimed to relieve nausea resulting from the four causative factors listed above. Therefore the intended use of the Psi Band and the predicate device are equivalent.

6. Comparison to Predicate Device:

Technical characteristics of the device(s) compared to the predicate device:

Image /page/1/Picture/16 description: The image contains three separate figures. The first figure appears to be a stick figure of a person. The second figure appears to be a table with many rows and columns. The third figure appears to be a plus sign with a stick figure in the middle.

606 Lighthouse Ave. #168 > Pacific Grove, CA 93950 Phone: [phone] ㆍ Fax: 831.373.774 ㆍ www.pslbands.com

2

Image /page/2/Picture/0 description: The image shows the word "PsiBands" in a stylized font. The letters are composed of small dots, giving the word a textured appearance. The word is displayed horizontally across the image.

Another healthy product from Psi Health Solutions, Inc.

	SUBJECT DEVICE	PREDICATE DEVICE
Feature	PSI Band	Acuband
510(k) Number	K070766	K053509
Intended Use	Relief of Nausea Caused
by Morning Sickness
(pregnancy), Motion
Sickness, Anesthesia, and
Chemotherapy	Relief of Nausea Caused by
Morning Sickness
(pregnancy), Motion
Sickness, Anesthesia, and
Chemotherapy
Length	9.33 inches	10.6 inches
Width	0.6 inches	0.8 inches
Wrist Circumference Limit	8.25 inches	8.5 inches
Band Composition	SantopreneTM
thermoplastic rubber and
medical grade ABS plastic	Nylon Hook and loop fabric
(VelcroTM) strap, Acrylic
Button and a Polypropylene
buckle
Pressure Adjustment	Yes, Adjustable	Yes, Adjustable
Button Composition	ABS Plastic Covered by
Medical Grade
SantopreneTM
Thermoplastic	Acrylic Plastic
Band Elasticity	Non-elastic	Non-elastic
Typical Button contact area	0.13 square inches	0.12 square inches
Button Dimensions
(Diameter)	0.40 inches	0.55 inches
Minimum contact pressure	0 pounds per square inch	0 pounds per square inch
Typical contact pressure	5-7 pounds per square inch	5-7 pounds per square inch

Table 1. Summary

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The performance outputs of the Psi Band and the predicate device, i.e., contact area and pressure exerted on the P6 (Nei-guan) pressure point were compared by bench testing.

Conclusions: The performance outputs of the subject device and the predicate device are equivalent.

8. Discussion of Clinical Tests Performed:

Not applicable. No clinical tests were performed.

Image /page/2/Picture/9 description: The image contains three separate figures. The first figure shows a person standing with their arms at their sides. The second figure shows a stack of boxes. The third figure shows a plus sign.

3

Image /page/3/Picture/0 description: The image shows the word "PsiBands" in a large font. Below the word, in a smaller font, is the text "Another hearthy product from Psi Health Solutions, Inc.". The text is centered below the word "PsiBands".

9. Conclusions:

The subject device has the same intended use and similar characteristics as the predicate device. Moreover, documentation supplied in this submission demonstrates that any differences in their technological characteristics or materials do not raise any new questions of safety or effectiveness. Thus, the Psi Band is substantially equivalent to the predicate device.

Image /page/3/Picture/3 description: The image contains three separate icons. The first icon depicts a person. The second icon depicts a calendar. The third icon depicts a plus sign.

606 Lighthouse Ave. #168 = Pacific Growp. CA 93950 Phone: $31.373.7712 = Fe's: $31.375.774 = www.psibands.com

4

Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2007

JUL 26 200

Psi Health Solutions, Inc. % Ms. Romy Taormina Co-Founder/Treasurer/Secretary 606 Lighthouse Ave #168 Pacific Grove, CA 93950

Re: K070766 Trade/Device Name: Psi Bands Regulation Name: Device, Acupressure Regulatory Class: unclassified (pre-ammendment) Product Code: MVV Dated: June 11, 2007 Received: June 13, 2007

Dear Ms. Taormina:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

5

Page 2 - Ms. Romy Taormina

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,
Mark A. Mulkeran

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Page 3 -

Indications for Use

510(k) Number (if known): K070766

Device Name: PsiBands

Indications For Use:

Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example:

• " Pregnancy (morning sickens)
• Motion sickness
• Anesthesia
• " Chemotherapy

Psi Bands are intended for over-the-counter use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) M

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number	K070766