| Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief |
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|---|---|---|---|---|
| 510(k) Number | K131513 | |||
| Device Name | SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY | |||
| Applicant |
|
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| Applicant Contact | larisa shpungina | |||
| Correspondent |
|
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| Correspodent Contact | larisa shpungina | |||
| Regulation Number | 882.5890 | |||
| Classification Product Code |
|
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| Subsequent Product Code |
|
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| Date Received | 05/28/2013 | |||
| Decision Date | 07/11/2014 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Neurology |
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| 510k Review Panel |
Neurology |
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| summary |
summary |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |