Identity
- Trade Name
- Equate FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. Device Description: Front and rear 8-inch solid wheels, acid batteries,black and red color of the scooter shell,with headlight. FDA UDI
- Model / Reference
- W3431D FDA UDI
- Description
- It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. Device Description: Front and rear 8-inch solid wheels, acid batteries,black and red color of the scooter shell,with headlight. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970765971478 FDA UDI
- 510(k) Number
- K062645 FDA UDI
- FDA Product Code
- INI FDA UDI
- GMDN Term
- Assistive scooter, electric-motor-driven 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 48 Kilogram FDA UDI
Category: Assistive scooter, electric-motor-driven
Equate by Walmart Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive scooter, electric-motor-driven.
- Pacesaver — Burke, Inc. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Legend XL — PRIDE MOBILITY PRODUCTS CORP. · Class II
- Go Go ES 3 Wheel — PRIDE MOBILITY PRODUCTS CORP. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Heartway Medical Products Co., Ltd — HEARTWAY MEDICAL PRODUCTS CO., LTD. · Class II
- Vive Mobility — VIVE HEALTH LLC · Class II
- FREERIDER — Freerider Corporation · Class II
Cleared under the same submission
K062645 also covers:
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
- Walmart Stores
Sources (1)
- FDA UDI f652b8e4-3417-42cc-b800-60919ffd14c8 36 fields · synced May 30, 2026