higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)

K172739 · Higi Sh, LLC · DXN · Oct 10, 2017 · Cardiovascular

Device Facts

• Record ID: K172739
• Device Name: higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
• Applicant: Higi Sh, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, percent lean body mass, percent body fat, total body water and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional.

Device Story

Higi Station is a public-access kiosk for self-service health monitoring. Inputs: blood pressure (via automated cuff), pulse, and body composition (via bioelectrical impedance analysis and weight scale). Operation: user sits at kiosk, applies cuff, and stands on scale; device processes signals to calculate physiological metrics. Output: display of measurements to user; optional storage or transmission to healthcare professionals. Context: point-of-care, retail, or public settings. Benefit: provides users with health data for consultation with physicians; not intended for diagnostic use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Noninvasive blood pressure measurement system (oscillometric); bioelectrical impedance analysis for body composition; weight scale; Pan and Tilt or Fixed cuff housing configurations; standalone kiosk form factor.

Indications for Use

Indicated for general public use for non-diagnostic measurement of blood pressure, pulse, body weight, percent lean body mass, percent body fat, total body water, and BMI calculation.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• higi Station (K152666)

Submission Summary (Full Text)

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October 10, 2017

higi SH LLC Colin Hill SVP Research & Development and Regulatory Affairs 800 Royal Oaks Dr. Suite 102 and 106 Monrovia, California 91016

Re: K172739

Trade/Device Name: higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station (with Body Composition and Fixed cuff housing) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, MNW Dated: September 8, 2017 Received: September 12, 2017

Dear Colin Hill:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M. A. Willemsen
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K172739

#### Device Name

higi Station (with Body Composition and Pan and Tilt cuff housing) higi Station (with Body Composition and Fixed cuff housing)

### Indications for Use (Describe)

The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, percent lean body mass, percent body fat, total body water and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) |
|---------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart G) |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|* | Over-The-Counter Use (21 CFR 801 Subpart C)

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