FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MED SCULPT
K Number: K053041
·
Decision Aug 2, 2006
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
5
Review Days
279
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Basic Information
- Device Name
- MED SCULPT
- K Number
- K053041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Project S.R.L.
- Date Received
- October 27, 2005
- Decision Date
- August 2, 2006
- 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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