The following data is part of a premarket notification filed by Phoenix Medical Devices, Llc with the FDA for Pmd-2000 Interferential Stimulator.
| Device ID | K042881 |
| 510k Number | K042881 |
| Device Name: | PMD-2000 INTERFERENTIAL STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PHOENIX MEDICAL DEVICES, LLC 620 NEWPORT CENTER SUITE 1100 Newport Beach, CA 92660 |
| Contact | Jim Klett |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2004-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860019001647 | K042881 | 000 |