| Primary Device ID | 04580657301010 |
| NIH Device Record Key | ce0df728-43db-4828-bf4b-e9729714b887 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TB12 VIBRATING PLIABILITY SPHERE |
| Version Model Number | VBALL-BLK-02A |
| Company DUNS | 698505802 |
| Company Name | DREAM FACTORY INC. |
| 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 04580657301027 - TB12 VIBRATING PLIABILITY MINI SPHERE | 2021-04-22 Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range |
| 04580657301010 - TB12 VIBRATING PLIABILITY SPHERE | 2021-01-20Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being. |
| 04580657301010 - TB12 VIBRATING PLIABILITY SPHERE | 2021-01-20 Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range |
| 04580657301003 - TB12 VIBRATING PLIABILITY ROLLER | 2021-01-14 Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range |