LogoFDA 510(k) Search
K Number
K172739
Device Name
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
Manufacturer
higi SH LLC
Date Cleared
2017-10-10

(28 days)

Product Code
DXN,MNW
Regulation Number
870.1130
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

Not Found

AI/ML Overview

I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a device called "higi Station." It primarily discusses the regulatory approval, classification, and general information about the device's intended use and compliance requirements.

However, the text does not contain any information regarding:

  • Acceptance criteria for device performance.
  • Details of a study proving the device meets acceptance criteria.
  • Sample sizes used for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC studies or effect sizes.
  • Stand-alone algorithm performance.
  • Type of ground truth used.
  • How ground truth for training data was established.

The document states the device name and its "Indications for Use," which describe what the device is intended for (measuring blood pressure, pulse, body weight, etc.) and specifies that it is "not a diagnostic device." It confirms substantial equivalence to predicate devices, but this approval doesn't detail performance testing.

Therefore, I lack the necessary information to construct the table or answer the specific questions about device performance studies and acceptance criteria.

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).