Empi
St. Paul, MN, US
Empi appears in FDA device records in St. Paul, MN. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Empi between 1997 and 2007. The busiest year on record is 1997, with 6. The most recent is 2007, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 6 |
| 1998 | 2 |
| 1999 | 1 |
| 2007 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | EGJ | Substantially Equivalent | |
| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | EGJ | Substantially Equivalent | |
| K061650 | SELECT TENS, MODEL 4600S | GZJ | Substantially Equivalent | |
| K991991 | DUPEL IONTOPHORESIS SYSTEM | EGJ | Substantially Equivalent | |
| K983484 | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE | EGJ | Substantially Equivalent | |
| K983206 | SMALL VAGINAL/RECTAL ELECTRODE | KPI | Substantially Equivalent | |
| K972054 | INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE | KPI | Substantially Equivalent | |
| K971527 | INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM | KPI | Substantially Equivalent | |
| K970491 | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES | EGJ | Substantially Equivalent | |
| K970307 | MINNOVA PELVIC FLOOR STIMULATION SYSTEM | KPI | Substantially Equivalent | |
| K970203 | EPIX VT | GZJ | Substantially Equivalent | |
| K964577 | INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) | KPI | 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