FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Power wheelchair (ZS-EW8026)
K Number: K254206
·
Decision Mar 27, 2026
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
1
Review Days
88
Basic Information
- Device Name
- Power wheelchair (ZS-EW8026)
- K Number
- K254206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ningbo Zhishan Medical Technology Co., Ltd.
- Date Received
- December 29, 2025
- Decision Date
- March 27, 2026
- 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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