FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORC BODY
K Number: K131291
·
Decision Jun 14, 2013
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
7
Review Days
39
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Basic Information
- Device Name
- TORC BODY
- K Number
- K131291
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johari Digital Healthcare , Ltd.
- Date Received
- May 6, 2013
- Decision Date
- June 14, 2013
- Product Code
- NGX
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Johari Digital Healthcare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K112351 | ULTRA BEAUTY | Mar 30, 2012 | Substantially Equivalent |
| K102190 | WINSTIM | Mar 17, 2011 | 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 |