FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Powered Wheelchair DYW30A(D09)
K Number: K170787
·
Decision Aug 9, 2017
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
2
Review Days
146
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Basic Information
- Device Name
- Powered Wheelchair DYW30A(D09)
- K Number
- K170787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
- Date Received
- March 16, 2017
- Decision Date
- August 9, 2017
- 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 Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201196 | Scooter (Model: FDB01) | Jun 25, 2021 | Substantially Equivalent |