The following data is part of a premarket notification filed by Orthosonix, Inc. with the FDA for Orthosonix Energex.
| Device ID | K013094 |
| 510k Number | K013094 |
| Device Name: | ORTHOSONIX ENERGEX |
| Classification | Device, Discharge, Electrostatic (for Pain Relief) |
| Applicant | ORTHOSONIX, INC. 615 7TH ST. NE 1ST FLOOR Washington, DC 20002 |
| Contact | Russell Pagano |
| Correspondent | Russell Pagano ORTHOSONIX, INC. 615 7TH ST. NE 1ST FLOOR Washington, DC 20002 |
| Product Code | NHH |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2001-12-14 |
| Summary: | summary |