FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
eFOLDi Scooter, Lite
K Number: K223492
·
Decision Feb 22, 2023
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
2
Review Days
93
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Basic Information
- Device Name
- eFOLDi Scooter, Lite
- K Number
- K223492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suntech UK , Ltd.
- Date Received
- November 21, 2022
- Decision Date
- February 22, 2023
- Product Code
- INI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
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Other Clearances by Suntech UK , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243110 | eFOLDi Navigator Powerchair (STPC-A) | May 8, 2025 | Substantially Equivalent |