| Primary Device ID | 00810203610773 | 
| NIH Device Record Key | 8e8310c0-1a73-4dec-b446-3eb5169ad739 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | COMFYGO | 
| Version Model Number | 6011 | 
| Catalog Number | 6011 | 
| Company DUNS | 094882026 | 
| Company Name | ComfyGO, Inc | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| 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 | 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 | 
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | |
| Phone | 18447555055 | 
| info@comfygomobility.com | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight. | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810203610773 [Primary] | 
| ITI | Wheelchair, Powered | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-09-22 | 
| Device Publish Date | 2025-09-12 | 
| 00810203610018 | Lightweight carbon fiber electric wheelchair with foldable frame, airline-approved lithium batte | 
| 00810203610728 | This device is a powered mobility aid intended to assist individuals with mobility difficulties. | 
| 00810203610773 | Electric Wheelchair | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  COMFYGO  97297376  not registered Live/Pending | ComfyGo, Inc. 2022-03-05 |