The following data is part of a premarket notification filed by Zynex Medical, Inc. with the FDA for Nexwave Combo Muscle Stimulator System.
| Device ID | K111279 |
| 510k Number | K111279 |
| Device Name: | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ZYNEX MEDICAL, INC. 9990 PARK MEADOWS DR Lone Tree, CO 80124 |
| Contact | Jim Arnold |
| Correspondent | Jim Arnold ZYNEX MEDICAL, INC. 9990 PARK MEADOWS DR Lone Tree, CO 80124 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-05 |
| Decision Date | 2011-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852670007007 | K111279 | 000 |