Identity
- Trade Name
- Amigo FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Amigo HD FDA UDI
- Model / Reference
- HD FDA UDI
- Description
- Amigo HD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863048000322 FDA UDI
- 510(k) Number
- K871391 FDA UDI
- FDA Product Code
- INF FDA UDI
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3940 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
No
FDA UDI
Category: Assistive scooter, electric-motor-driven
Amigo by Amigo Mobility International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K871391 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 I | Pending data |
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Manufacturer
- Manufacturer
- Amigo Mobility International, Inc.
Sources (1)
- FDA UDI 6202a89a-ba3d-4a5c-8f66-34aeaa29ab4f 34 fields · synced Jun 1, 2026