| Primary Device ID | 00860013229061 |
| NIH Device Record Key | b7befc06-0a0d-4c62-97a1-945d3aac803a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONLUX |
| Version Model Number | OLF3009 |
| Company DUNS | 122389660 |
| Company Name | PHYSIOHAB LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860013229061 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-03 |
| Device Publish Date | 2025-03-26 |
| 00860013229085 | LED infrared light therapy wrap for amputees |
| 00860013229078 | LED Infrared therapy wrap for the elbow |
| 00860013229061 | LED Infrared therapy device for the foot |
| 00860013229054 | LED Infrared light therapy wrap for the ankle |
| 00860013229047 | LED Infrared light therapy wrap for the Knee |
| 00860013229023 | ONLUX Shoulder LED Infrared therapy device |
| 00860013229016 | LED Infrared Therapy device for the hand |
| 00860013229009 | LED Infrared therapy device for the lumbar |
| 00860013229030 | LED Infrared therapy device for the Neck |