FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WALKAIDE SYSTEM
K Number: K140886
·
Decision Aug 8, 2014
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
3
Review Days
123
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Basic Information
- Device Name
- WALKAIDE SYSTEM
- K Number
- K140886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5810
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Neurotronics, Inc.
- Date Received
- April 7, 2014
- Decision Date
- August 8, 2014
- Product Code
- GZI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | FDA class 2 | Neurology |
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