| Primary Device ID | 00860009854581 |
| NIH Device Record Key | b386f115-2195-43e8-888a-7f53548199a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foot Vitalizer |
| Version Model Number | Foot Vitalizer |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009854581 [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 |
| 00860009854581 - Foot Vitalizer | 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 |