Identity
- Trade Name
- FORCEMECH FDA UDI
- Generic Name
- Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible FDA UDI
- Device Name
- Foldable Electric Wheelchair FDA UDI
- Model / Reference
- NAVIGATOR XL FDA UDI
- Description
- Foldable Electric Wheelchair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008903693 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Forcemech by Forcemech International Llc. — 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.
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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.
- 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
- Forcemech International Llc.
Sources (1)
- FDA UDI 975e9989-763c-4b2d-9f99-dbef8ef65203 34 fields · synced Jun 6, 2026