FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Muscle Stimulation System 110
K Number: K150742
·
Decision Jul 23, 2015
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
2
Review Days
122
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Basic Information
- Device Name
- Muscle Stimulation System 110
- K Number
- K150742
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Niveus Medical, Inc.
- Date Received
- March 23, 2015
- Decision Date
- July 23, 2015
- 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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Other Clearances by Niveus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123642 | MUSCLE STIMULATION SYSTEM | Mar 29, 2013 | Substantially Equivalent |