FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
F5 Corpus VS
K Number: K191874
·
Decision Oct 25, 2019
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
65
Applicant Total
15
Review Days
105
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Basic Information
- Device Name
- F5 Corpus VS
- K Number
- K191874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Permobil AB
- Date Received
- July 12, 2019
- Decision Date
- October 25, 2019
- Product Code
- IPL
- 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 |
|---|---|---|---|
| IPL | Wheelchair, Standup | FDA class 2 | Physical Medicine |
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Other Clearances by Permobil AB
| K Number | Device Name | ||
|---|---|---|---|
| K190682 | Explorer Mini | Feb 27, 2020 | Substantially Equivalent |
| K143180 | F3 | Mar 27, 2015 | Substantially Equivalent |
| K143014 | F5 | Mar 25, 2015 | Substantially Equivalent |
| K123290 | M300 & M400 | Apr 17, 2013 | Substantially Equivalent |
| K103477 | PERMOBIL M300 / M400 | Mar 3, 2011 | Substantially Equivalent |
| K081964 | K450 POWERED WHEELCHAIR | Jul 29, 2008 | Substantially Equivalent |
| K071650 | C350 POWERED WHEELCHAIR | Sep 12, 2007 | Substantially Equivalent |
| K041219 | ELECTRO | Aug 4, 2004 | Substantially Equivalent |
| K032765 | STREET | Jan 30, 2004 | Substantially Equivalent |
| K993406 | TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 | Dec 18, 2000 | Substantially Equivalent |