| Primary Device ID | 00858985006049 |
| NIH Device Record Key | 9d97be3a-90f4-4768-b766-693b1924d3eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX635 |
| Version Model Number | HPS |
| Catalog Number | HPS |
| Company DUNS | 004053174 |
| Company Name | ERCHONIA CORPORATION, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com | |
| Phone | (888) 242-0571 |
| info@erchonia.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858985006049 [Primary] |
| NHN | Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2019-09-09 |
| Device Publish Date | 2016-09-24 |
| 00858985006049 | MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction of Musculoskeletal |
| 00858985006186 | MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction |