FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STIMEL-03
K Number: K130424
·
Decision Jul 11, 2013
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
1
Review Days
141
Basic Information
- Device Name
- STIMEL-03
- K Number
- K130424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- STIMEL LTD
- Date Received
- February 20, 2013
- Decision Date
- July 11, 2013
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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