FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K Number: K090052
·
Decision May 29, 2009
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
18
Applicant Total
7
Review Days
142
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Basic Information
- Device Name
- CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
- K Number
- K090052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johari Digital Healthcare , Ltd.
- Date Received
- January 7, 2009
- Decision Date
- May 29, 2009
- Product Code
- QJQ
- 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 |
|---|---|---|---|
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | FDA class 2 | Neurology |
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Other Clearances by Johari Digital Healthcare , Ltd.
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|---|---|---|---|
| K131291 | TORC BODY | Jun 14, 2013 | Substantially Equivalent |
| K112351 | ULTRA BEAUTY | Mar 30, 2012 | Substantially Equivalent |
| K102190 | WINSTIM | Mar 17, 2011 | 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 |