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 |