Higi Green (KMY) n/a

GUDID B416KMY8202F0

The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, 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 choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.

HIGI SH LLC

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: B416KMY8202F0
• NIH Device Record Key: 0402f17e-ea7b-4d91-b1d8-cf9281ba1bd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Higi Green (KMY)
• Version Model Number: KMY-120630950-117
• Catalog Number: n/a
• Company DUNS: 079773850
• Company Name: HIGI SH LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B416KMY8202F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151127

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-09-20

Devices Manufactured by HIGI SH LLC

• B146ZT2776A00210 - higi SZZT: 2019-11-08 The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, perc
• B416KMY8202F0 - Higi Green (KMY): 2019-11-08The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, 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 choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
• B416KMY8202F0 - Higi Green (KMY): 2019-11-08 The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, perc
• B416SH650 - Higi White: 2019-11-08 The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, perc