| Primary Device ID | 00860001790825 |
| NIH Device Record Key | 5d238454-6cd1-4399-b427-dd0ce57bbf5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InTandem Education Unit |
| Version Model Number | 001EDU |
| Company DUNS | 080565076 |
| Company Name | Medrhythms, 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 | false |
| 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 | 00860001790825 [Primary] |
| HCC | Device, Biofeedback |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-23 |
| Device Publish Date | 2025-06-13 |
| 00860001790825 - InTandem Education Unit | 2025-06-23Education Unit for InTandem |
| 00860001790825 - InTandem Education Unit | 2025-06-23 Education Unit for InTandem |
| 00860001790832 - Movive Education Unit | 2025-06-23 Education Unit for Movive |
| 00860001790818 - Movive | 2025-03-18 Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is inte |
| 00860001790801 - InTandem | 2023-11-06 InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the |