FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
LANDLEX, MODEL S300X
K Number: K050792
·
Decision Apr 21, 2005
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
5
Review Days
24
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Basic Information
- Device Name
- LANDLEX, MODEL S300X
- K Number
- K050792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cycling and Health Tech. Industry R&D Center
- Date Received
- March 28, 2005
- Decision Date
- April 21, 2005
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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