FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Invacare TDX SP2-HD with Captain's Seat
K Number: K182946
·
Decision Dec 11, 2018
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
20
Review Days
49
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Basic Information
- Device Name
- Invacare TDX SP2-HD with Captain's Seat
- K Number
- K182946
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invacare Corporation
- Date Received
- October 23, 2018
- Decision Date
- December 11, 2018
- 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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| K162696 | Kuschall Advance Manual Wheelchair | Dec 28, 2016 | Substantially Equivalent |
| K162692 | Kuschall K-Series Attract Manual Wheelchair | Dec 28, 2016 | Substantially Equivalent |