FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
HP358EA Electrically Powered Wheelchair
K Number: K211647
·
Decision Jan 4, 2022
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
9
Review Days
221
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Basic Information
- Device Name
- HP358EA Electrically Powered Wheelchair
- K Number
- K211647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kunshan Hi-Fortune Health Products Co., Ltd.
- Date Received
- May 28, 2021
- Decision Date
- January 4, 2022
- 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 Kunshan Hi-Fortune Health Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K244003 | Electrically powered wheelchair | Mar 26, 2025 | Substantially Equivalent |
| K243962 | Electrically Powered Wheelchair | Feb 12, 2025 | Substantially Equivalent |
| K243961 | Electrically Powered Wheelchair | Feb 12, 2025 | Substantially Equivalent |
| K241337 | Electrically powered wheelchair (HP202) | Oct 17, 2024 | Substantially Equivalent |
| K241632 | Electrically powered wheelchair | Oct 16, 2024 | Substantially Equivalent |
| K212503 | HP458E Electrically Powered Wheelchair | Jan 18, 2022 | Substantially Equivalent |
| K201855 | Electrically Powered Wheelchair -Model HP358E | Sep 28, 2021 | Substantially Equivalent |
| K163352 | Wheelchair | Jul 28, 2017 | Substantially Equivalent |