American Imex
Irvine, CA, US
American Imex appears in FDA device records in Irvine, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for American Imex between 1986 and 2004. The busiest year on record is 1988, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1998 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032003 | PREMIER PLUS | GZJ | Substantially Equivalent | |
| K982221 | PREMIER AP | GZJ | Substantially Equivalent | |
| K926326 | MICROCARE(TM) | GZJ | Substantially Equivalent | |
| K912289 | ULTIMA XS, MODIFICATION | GZJ | Substantially Equivalent | |
| K895295 | ULTIMA XS MICROCURRENT TENS | GZJ | Substantially Equivalent | |
| K894388 | ZIMMER TENS | GZJ | Substantially Equivalent | |
| K881704 | EASY TENS | GZJ | Substantially Equivalent | |
| K881424 | PREMIER 10S (TENS) | GZJ | Substantially Equivalent | |
| K880751 | ULTIMA XS (TENS) | GZJ | Substantially Equivalent | |
| K864735 | A-TENS - MODEL AI-87 | GZJ | Substantially Equivalent | |
| K861709 | A TENS (MODEL AI-86) | GZJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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