| Primary Device ID | 00860009854574 |
| NIH Device Record Key | 6625944a-e4a0-4176-be1f-035b48923be4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PremierRLT |
| Version Model Number | PremierRLT |
| Company DUNS | 876724449 |
| Company Name | Body Balance System, 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com | |
| Phone | 111-111-1111 |
| light@solariusspa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009854574 [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 | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 00860009854543 - Apollo | 2025-03-12 |
| 00860009854550 - Apollo | 2025-03-12 |
| 00860009854567 - Ovation | 2025-03-12 |
| 00860009854574 - PremierRLT | 2025-03-12 |
| 00860009854574 - PremierRLT | 2025-03-12 |
| 00860009854581 - Foot Vitalizer | 2025-03-12 |
| 00860009854536 - OvationULT | 2024-07-01 The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to |
| 00860009854529 - Ovation | 2023-09-26 The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to |