Data / Medical devices / United States / Higi SH LLC
Higi SH LLC: FDA-registered device maker in Chicago, IL, United States, 6 510(k) clearances
Higi SH LLC is registered with the FDA (registration 3003703880) in Chicago, IL, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 10, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003703880
- Address
- 20 N Wacker Dr Ste 1642, Chicago, IL, United States, 60606
- Owner or operator
- higi SH LLC (10032072)
- Roles
- Specification developer
- First device listed
- April 6, 2010
- Registered through
- 2027
- Brand names listed
- Analyzer Body Composition, BC4, Body Composition Analyzer, HIGI Kiosk, HIGI Station, Stayhealthy Health Kiosk, Stayhealthy HealthCENTER Kiosk, higi Station and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | accessdata.fda.gov |
| Tester, Color Vision | HIT | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2017 | K172739 | higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) | DXN | Substantially Equivalent | Higi Sh, LLC | accessdata.fda.gov |
| December 8, 2015 | K151127 | higi Station | DXN | Substantially Equivalent | Higi Sh, LLC | accessdata.fda.gov |
| April 22, 2013 | K123539 | STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK | DXN | Substantially Equivalent | Stayhealthy, Inc. | accessdata.fda.gov |
| January 26, 2011 | K101807 | STAYHEALTHY BODY COMPOSITION MONITOR-BCM | MNW | Substantially Equivalent | Stayhealthy, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052522 | STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 | MNW | Substantially Equivalent | Stayhealthy, Inc. | accessdata.fda.gov |
| August 31, 2004 | K040562 | LIFECLINIC, MODEL 2400 | DXN | Substantially Equivalent | Lifeclinic International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Tester, Color Vision
Updated October 10, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.