FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SW-180 SHORTWAVE THERAPY UNIT
K Number: K022846
·
Decision Jan 28, 2003
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
8
Review Days
154
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Basic Information
- Device Name
- SW-180 SHORTWAVE THERAPY UNIT
- K Number
- K022846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ito Co., Ltd.
- Date Received
- August 27, 2002
- Decision Date
- January 28, 2003
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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