| Primary Device ID | 00718175004302 |
| NIH Device Record Key | 80a0ce89-a886-4e91-b05d-39bce5876034 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VibroTactile |
| Version Model Number | 950-430 |
| Company DUNS | 043833813 |
| Company Name | BIODEX MEDICAL SYSTEMS, 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00718175004302 [Primary] |
| KHX | Platform, Force-Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| 00718175002407 - Biostep 2, 100-240 VAC | 2024-05-14 950-240 Biostep 2, 100-240 VAC |
| 00718175006009 - Reactive Step Trainer 115V | 2024-05-14 950-600 Reactive Step Trainer 115V |
| 00718175001462 - Biodex | 2023-08-10 CYCLE, UPPER BODY |
| 00718175001486 - Biodex | 2023-08-10 CYCLE, UPPER BODY - CLINICAL PRO |
| 00718175005606 - Sit2Stand | 2023-08-08 SIT2STAND SQUAT-ASSIST TRAINER |
| 00718175004302 - VibroTactile | 2023-07-27VIBROTACTILE BELT KIT |
| 00718175004302 - VibroTactile | 2023-07-27 VIBROTACTILE BELT KIT |
| 00718175087640 - BETA, Syringe Shield | 2021-01-15 BETA, Lead Encapsulated Syringe Shield, 20cc |
| 00718175087626 - VENTI-SCAN IV | 2020-10-23 Venti-Scan IV, Includes shielded canister with IV pole mount |