| Primary Device ID | G144FM0 |
| NIH Device Record Key | ac3b32bf-79a2-4dfb-b5b4-c691e590fdb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flint Rehab |
| Version Model Number | FM |
| 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 | G144FM0 [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 | 2023-08-18 |
| Device Publish Date | 2023-08-10 |
| 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 |