FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERTONE, MODEL PT-11
K Number: K062439
·
Decision Jan 8, 2007
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
7
Review Days
140
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Basic Information
- Device Name
- POWERTONE, MODEL PT-11
- K Number
- K062439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johari Digital Healthcare , Ltd.
- Date Received
- August 21, 2006
- Decision Date
- January 8, 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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