FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONIC-STIM
K Number: K063135
·
Decision Feb 5, 2007
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
3
Review Days
112
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Basic Information
- Device Name
- SONIC-STIM
- K Number
- K063135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Naimco, Inc.
- Date Received
- October 16, 2006
- Decision Date
- February 5, 2007
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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