FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
Flexx Junior (FLX-J00, FLX-J50)
K Number: K250576
·
Decision Nov 4, 2025
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
1
Review Days
250
Basic Information
- Device Name
- Flexx Junior (FLX-J00, FLX-J50)
- K Number
- K250576
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karma Mobility Co, Ltd.
- Date Received
- February 27, 2025
- Decision Date
- November 4, 2025
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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