Identity
- Trade Name
- MEDACURE FDA UDI
- Generic Name
- Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible FDA UDI
- Device Name
- WINGS FDA UDI
- Model / Reference
- PW2018 FDA UDI
- Description
- WINGS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853223008106 FDA UDI
- 510(k) Number
- K070501 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Medacure by Medacure Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible.
- Tek RMD — MATIA ROBOTICS (US), INC. · Class II
- Tek RMD — MATIA ROBOTICS (US), INC. · Class II
- Tek RMD — MATIA ROBOTICS (US), INC. · Class II
- FORCEMECH — FORCEMECH INTERNATIONAL LLC. · Class II
- FORCEMECH — FORCEMECH INTERNATIONAL LLC. · Class II
- FORCEMECH — FORCEMECH INTERNATIONAL LLC. · Class II
- FORCEMECH — FORCEMECH INTERNATIONAL LLC. · Class II
- Tek RMD — MATIA ROBOTICS (US), INC. · Class II
Cleared under the same submission
K070501 also covers:
- COMFYGO — ComfyGO, Inc
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- FORCEMECH — FORCEMECH INTERNATIONAL LLC.
- 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
- Medacure Inc
Sources (1)
- FDA UDI a18a251d-3c87-4c1b-8fe2-704bdb67d9a1 34 fields · synced May 31, 2026