FDA UDI
In Commercial Distribution
🇺🇸 United States
ComfyGO
DI: 00810203610728
·
Model: G-5
·
ComfyGO, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ComfyGO
- Primary DI
- 00810203610728
- Version / Model
- G-5
- Catalog Number
- G-5
- Company Name
- ComfyGO, Inc
- Labeler DUNS
- 094882026
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-11
- Public Version
- 1
- Public Version Date
- 2025-09-19
- Public Version Status
- New
- Public Device Record Key
- 0c7e03d1-ab9a-48c6-adbb-ac0ecbfe4809
Device Description
This device is a powered mobility aid intended to assist individuals with mobility difficulties. It features an electric motor system, a foldable and portable frame, and is designed for ease of use. The device includes basic user controls for direction and speed, that provide support and safety for the user. It is suitable for use in various environments, including both indoor and outdoor settings, and is designed to be durable, user-friendly, and low-maintenance.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41875 | Electric-motor-driven wheelchair, occupant-controlled | An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810203610728 | GS1 |
Customer Contacts
- Phone
- +18447555055
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240563 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.