The following data is part of a premarket notification filed by Axiom Worldwide, Inc. with the FDA for Axiom Nvp8500.
| Device ID | K051135 |
| 510k Number | K051135 |
| Device Name: | AXIOM NVP8500 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | AXIOM WORLDWIDE, INC. 9423 CORPORATE LAKE DRIVE Tampa, FL 33634 |
| Contact | James J Gibson |
| Correspondent | James J Gibson AXIOM WORLDWIDE, INC. 9423 CORPORATE LAKE DRIVE Tampa, FL 33634 |
| Product Code | IPF |
| Subsequent Product Code | GXY |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-03 |
| Decision Date | 2005-08-11 |
| Summary: | summary |