Identity
- Trade Name
- Drive FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Spitfire Pro, 4-Wheel 17" Seat, 21AH FDA UDI
- Model / Reference
- SFPRO417FS-21 FDA UDI
- Description
- Spitfire Pro, 4-Wheel 17" Seat, 21AH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383991788 FDA UDI
- 510(k) Number
- K051473 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
Yes
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
Drive by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Assistive scooter, electric-motor-driven.
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Cleared under the same submission
K051473 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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI a4038fb7-3f8c-488d-8e15-1686ce74cc38 34 fields · synced Jun 8, 2026