Higi Station (with Body Composition And Pan And Tilt Cuff Housing), Higi Station ( With Body Composition And Fixed Cuff Housing)
Higi SH LLC
HIGI SH LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003703880 | 3003703880 | HIGI SH LLC | 1 | N | 2026-01-01 | 20 N Wacker Dr Ste 1642 Chicago IL US 60606 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 115756 | 2019487754 | K172739 | higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) | DXN | 2017-10-10 |
| 115756 | 1041067818 | K151127 | higi Station | DXN | 2015-12-08 |
| 115756 | 1844463564 | K123539 | STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK | DXN | 2013-04-22 |
| 115756 | 1358823337 | K101807 | STAYHEALTHY BODY COMPOSITION MONITOR-BCM | MNW | 2011-01-26 |
| 115756 | 1253761690 | K052522 | STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 | MNW | 2005-12-13 |
| 115756 | 1025505630 | K040562 | LIFECLINIC, MODEL 2400 | DXN | 2004-08-31 |
Product Codes Associated With Registrations#
PMN#
Higi Station
Higi SH LLC
GUDID#
higi SZZT - 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.
2018-09-20
Higi Green (KMY) - 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.
2018-09-20
Higi White - 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.
2018-09-20