Higi SH LLC
Chicago, IL, US
HIGI SH LLC appears in FDA device records in Chicago, IL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Higi SH LLC between 2015 and 2017. The busiest year on record is 2015, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172739 | higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) | DXN | Substantially Equivalent | |
| K151127 | higi Station | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003703880 | 3003703880 | HIGI SH LLC | 20 N Wacker Dr Ste 1642, Chicago, IL 60606 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain