Empi
Arden Hills, MN, US
Empi appears in FDA device records in Arden Hills, MN. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Empi between 1988 and 1996. The busiest year on record is 1989, with 5. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1989 | 5 |
| 1990 | 5 |
| 1991 | 3 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951951 | FOCUS MODEL 795 UNIT | GZJ | Substantially Equivalent | |
| K951903 | EPIX XL TENS UNIT | GZJ | Substantially Equivalent | |
| K941911 | INNOVA PELVIC FLOOR STIMULATION SYSTEM | KPI | Substantially Equivalent | |
| K940091 | INNOVA VAGINAL EMG SENSING ELECTRODE | HIR | Substantially Equivalent | |
| K941389 | EMPI TAPE PATCHES | KGX | Substantially Equivalent | |
| K915444 | DUPEL IONTOPHORESIS DEVICE | EGJ | Substantially Equivalent | |
| K912015 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 | EGJ | Substantially Equivalent | |
| K912014 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 | EGJ | Substantially Equivalent | |
| K910081 | TBD | KPI | Substantially Equivalent | |
| K903093 | IONTOPHORESIS DEVICE | EGJ | Unknown | |
| K902195 | TBD TENS REUSABLE ELECTRODE | GXY | Substantially Equivalent | |
| K901103 | MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE | GXY | Substantially Equivalent | |
| K901102 | MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE | GXY | Substantially Equivalent | |
| K896703 | TBD IONTOPHORESIS ELECTRODE | EGJ | Unknown | |
| K896485 | MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN | GXY | Substantially Equivalent | |
| K890604 | EMPI, MODEL 489, TENS | GZJ | Substantially Equivalent | |
| K890747 | EMPI REUSEABLE PIN-STYLE TENS ELECTRODE | GXY | Substantially Equivalent | |
| K890614 | EMPI MULTIDAY TENS DISPOSABLE ELECTRODE | GXY | Substantially Equivalent | |
| K890605 | EMPI ISLAND TENS ELECTRODE | GXY | Substantially Equivalent | |
| K882631 | EMPI MODEL 727,NMS | GZJ | Substantially Equivalent | |
| K881114 | EMPI MODEL 989, TENS | 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