FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
WINSTIM
K Number: K102190
·
Decision Mar 17, 2011
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
7
Review Days
226
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Basic Information
- Device Name
- WINSTIM
- K Number
- K102190
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johari Digital Healthcare , Ltd.
- Date Received
- August 3, 2010
- Decision Date
- March 17, 2011
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Johari Digital Healthcare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K131291 | TORC BODY | Jun 14, 2013 | Substantially Equivalent |
| K112351 | ULTRA BEAUTY | Mar 30, 2012 | Substantially Equivalent |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | May 29, 2009 | Substantially Equivalent |
| 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 |