FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBUS PREMIUM MUSCLE STIMULATOR
K Number: K061632
·
Decision Apr 30, 2007
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
2
Review Days
322
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Basic Information
- Device Name
- GLOBUS PREMIUM MUSCLE STIMULATOR
- K Number
- K061632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Domino S.R.L.
- Date Received
- June 12, 2006
- Decision Date
- April 30, 2007
- Product Code
- NGX
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Domino S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K071431 | GLOBUS GENESY 1100 STIMULATOR | Sep 21, 2007 | Substantially Equivalent |