The following data is part of a premarket notification filed by Empi with the FDA for Empi Continuum.
| Device ID | K093324 |
| 510k Number | K093324 |
| Device Name: | EMPI CONTINUUM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EMPI 4717 ADAMS ROAD Hixson, TN 37343 |
| Contact | Jo P Chiu |
| Correspondent | Jo P Chiu EMPI 4717 ADAMS ROAD Hixson, TN 37343 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-23 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B36711402L00 | K093324 | 000 |