FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
eFOLDi Navigator Powerchair (STPC-A)
K Number: K243110
·
Decision May 8, 2025
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
2
Review Days
220
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Basic Information
- Device Name
- eFOLDi Navigator Powerchair (STPC-A)
- K Number
- K243110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suntech UK , Ltd.
- Date Received
- September 30, 2024
- Decision Date
- May 8, 2025
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Suntech UK , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223492 | eFOLDi Scooter, Lite | Feb 22, 2023 | Substantially Equivalent |