FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PERMOBIL M300 / M400
K Number: K103477
·
Decision Mar 3, 2011
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
15
Review Days
97
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Basic Information
- Device Name
- PERMOBIL M300 / M400
- K Number
- K103477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Permobil AB
- Date Received
- November 26, 2010
- Decision Date
- March 3, 2011
- 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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| K143180 | F3 | Mar 27, 2015 | Substantially Equivalent |
| K143014 | F5 | Mar 25, 2015 | Substantially Equivalent |
| K123290 | M300 & M400 | Apr 17, 2013 | 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 |