JKH USA, LLC
Walnut, CA, US
JKH USA, LLC appears in FDA device records in Walnut, CA. FDA records list 9 510(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 9 510(k) clearances for JKH USA, LLC between 2019 and 2021. The busiest year on record is 2019, with 3. The most recent is 2021, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203636 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG | FLL | Substantially Equivalent | |
| K203635 | Patient Monitoring Cables | DSA | Substantially Equivalent | |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D | DXQ | Substantially Equivalent | |
| K202851 | Spo2 Sensor | DQA | Substantially Equivalent | |
| K201645 | Massage Compression Boots | IRP | Substantially Equivalent | |
| K201470 | Disposable Medical Face Mask | FXX | Substantially Equivalent | |
| K182671 | Medi-Direct TENS Pen | NUH | Substantially Equivalent | |
| K191151 | JKH Stimulator Plus | NUH | Substantially Equivalent | |
| K182203 | JKH Stimulator Plus | NUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015060237 | 3015060237 | JKH USA, LLC | 611 Reyes, Walnut, CA 91789 US | 2026 | No device listings on this registration |
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