FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
N5-1
K Number: K153054
·
Decision Feb 5, 2016
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
65
Applicant Total
3
Review Days
108
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Basic Information
- Device Name
- N5-1
- K Number
- K153054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuga Medical Co., Ltd.
- Date Received
- October 20, 2015
- Decision Date
- February 5, 2016
- Product Code
- JFB
- 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 |
|---|---|---|---|
| JFB | Table, Physical Therapy, Multi Function | FDA class 2 | Physical Medicine |
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