| Primary Device ID | G144MGML0 |
| NIH Device Record Key | 797b8f6f-c235-400f-bb61-c73ccdb12dd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flint Rehab |
| Version Model Number | MGML |
| Company DUNS | 078285646 |
| Company Name | Flint Rehabilitation Devices 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 | true |
| Serial Number | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G144MGML0 [Primary] |
| ION | Exerciser, Non-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 | 2023-08-21 |
| Device Publish Date | 2023-08-11 |
| G144FMT0 | FitMi Exercise System with Tablet |
| G144FM0 | FitMi Exercise System |
| G144AFO0 | Flex AFO |
| G144MGSR0 | MusicGlove Exercise System - Small Right |
| G144MGSL0 | MusicGlove Exercise System - Small Left |
| G144MGML0 | MusicGlove Exercise System - Medium Left |
| G144MGLL0 | MusicGlove Exercise System - Large Left |
| G144MGT0 | MusicGlove Exercise System with Tablet |
| G144MGMR0 | MusicGlove Exercise System - Medium Right |
| G144MGLR0 | MusicGlove Exercise System - Large Right |