The following data is part of a premarket notification filed by Empi with the FDA for 300 Pv Complete Electrotherapy System.
| Device ID | K021100 |
| 510k Number | K021100 |
| Device Name: | 300 PV COMPLETE ELECTROTHERAPY SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EMPI 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer EMPI 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IPF |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-04 |
| Decision Date | 2002-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B36711008L00 | K021100 | 000 |