The following data is part of a premarket notification filed by Medico Electrodes International Ltd. with the FDA for Flexstim Neurostimulation Electrodes Model Numbers: 5050roc1s, 5050roc1w, 5050roc2s, 5050roc2w, 5050sqc1s, 5050sqc1w, 5050sqc2s, 5050sqc2w.
| Device ID | K161282 |
| 510k Number | K161282 |
| Device Name: | FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W |
| Classification | Electrode, Cutaneous |
| Applicant | MEDICO ELECTRODES INTERNATIONAL LTD. PLOT 142A/AA, 12, 27, 28 & 29, NOIDA SPECIAL ECONOMIC ZONE Noida, IN 201305 |
| Contact | Amit Seth |
| Correspondent | Amit Seth MEDICO ELECTRODES INTERNATIONAL LTD. PLOT 142A/AA, 12, 27, 28 & 29, NOIDA SPECIAL ECONOMIC ZONE Noida, IN 201305 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-06 |
| Decision Date | 2016-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818323027898 | K161282 | 000 |