FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
K Number: K011913
·
Decision Oct 26, 2001
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
3
Review Days
129
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Basic Information
- Device Name
- SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
- K Number
- K011913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sun-Rain System Corp.
- Date Received
- June 19, 2001
- Decision Date
- October 26, 2001
- 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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