Identity
- Trade Name
- COMFYGO FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electric Wheelchair FDA UDI
- Model / Reference
- 6011 FDA UDI
- Description
- Electric Wheelchair FDA UDI
Identifiers
- Catalog Number
- 6011 FDA UDI
- Primary DI / UDI-DI
- 00810203610773 FDA UDI
- 510(k) Number
- K070501 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electric-motor-driven wheelchair, occupant-controlled
Comfygo by ComfyGO, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric-motor-driven wheelchair, occupant-controlled.
- YOUHUAN — Ningbo Youhuan Automation Technology Co., Ltd · Class II
- WHILL, Inc. — WHILL, INC. · Class II
- Permobil — PERMOBIL, INC. · Class II
- MODULAR POWER POSITIONING SYSTEM — Motion Concepts Inc · Class II
- XSTO — XSTO CO., LTD. · Class II
- INVACARE® TDX® POWER WHEELCHAIR — Invacare Corp. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Merits — MERITS HEALTH PRODUCTS., INC. · Class II
Cleared under the same submission
K070501 also covers:
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- MEDACURE — MEDACURE INC
- Electric wheelchair — Zhejiang Innuovo Rehabilitation Devices Co., Ltd
- Innuovo — Zhejiang Innuovo Rehabilitation Devices Co., Ltd
- Power Wheelchair — Zhejiang Innuovo Rehabilitation Devices Co., Ltd
- Power Wheelchair — Zhejiang Innuovo Rehabilitation Devices Co., Ltd
- Power Wheelchair — Zhejiang Innuovo Rehabilitation Devices Co., Ltd
- Power Wheelchair — Zhejiang Innuovo Rehabilitation Devices Co., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ComfyGO, Inc
Sources (1)
- FDA UDI 8e8310c0-1a73-4dec-b446-3eb5169ad739 37 fields · synced Jun 8, 2026