The following data is part of a premarket notification filed by Neux Technologies, Inc. with the FDA for Nxpro Neuromuscular Electrical Stimulation Device.
| Device ID | K191181 |
| 510k Number | K191181 |
| Device Name: | NXPRO Neuromuscular Electrical Stimulation Device |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | NeuX Technologies, Inc. 3802 Spectrum Blvd. Suite 112F Tampa, FL 33612 |
| Contact | Scot Minniear |
| Correspondent | Christopher J. Devine Devine Guidance International, Inc. 4730 South Fort Apache Road, Suite 300 Las Vegas, NV 89147 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-02 |
| Decision Date | 2019-10-11 |
| Summary: | summary |