FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
ULTRA BEAUTY
K Number: K112351
·
Decision Mar 30, 2012
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
7
Review Days
227
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Basic Information
- Device Name
- ULTRA BEAUTY
- K Number
- K112351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johari Digital Healthcare , Ltd.
- Date Received
- August 16, 2011
- Decision Date
- March 30, 2012
- Product Code
- NFO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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| K062439 | POWERTONE, MODEL PT-11 | Jan 8, 2007 | Substantially Equivalent |
| K060246 | INFREX | May 5, 2006 | Substantially Equivalent |
| K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 | Dec 20, 2002 | Substantially Equivalent |