FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SENSOR WALK
K Number: K052771
·
Decision May 3, 2006
Classifications
1
FEI Numbers
503
Registration Numbers
503
Same Product Code
51
Applicant Total
17
Review Days
215
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Basic Information
- Device Name
- SENSOR WALK
- K Number
- K052771
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otto Bock Healthcare LP
- Date Received
- September 30, 2005
- Decision Date
- May 3, 2006
- Product Code
- IQI
- 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | FDA class 1 | Physical Medicine |
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