FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
SUN-RAIN ULTRASONIC THERAPY, SU-100
K Number: K024013
·
Decision Oct 31, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
3
Review Days
331
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Basic Information
- Device Name
- SUN-RAIN ULTRASONIC THERAPY, SU-100
- K Number
- K024013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sun-Rain System Corp.
- Date Received
- December 4, 2002
- Decision Date
- October 31, 2003
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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