Identity
- Trade Name
- Zip'r 4 FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Zip'r 4 Wheel XTRA Traveler Mobility Scooter blue 10017012 FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- Zip'r 4 Wheel XTRA Traveler Mobility Scooter blue 10017012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972356130080 FDA UDI
- 510(k) Number
- K102361 FDA UDI
- FDA Product Code
- INI FDA UDI
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3800 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
Yes
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: Electric-motor-driven wheelchair, occupant-controlled
Zip'r 4 by Global Fabtech (shanghai) Co., Ltd. — 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
K102361 also covers:
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) CO., LTD.
- Zip'r 4 — GLOBAL FABTECH (SHANGHAI) 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
- Global Fabtech (shanghai) Co., Ltd.
Sources (1)
- FDA UDI e66ed235-8a22-4c29-bf2f-6babcdf2ea5d 34 fields · synced May 30, 2026