The following data is part of a premarket notification filed by Synapse Electroceutical Limited with the FDA for Synapse Transcutaneous Electrical Stimulation Device.
| Device ID | K143198 |
| 510k Number | K143198 |
| Device Name: | Synapse Transcutaneous Electrical Stimulation Device |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Synapse Electroceutical Limited 1 Churchill Court, Hortons Way Westerham, GB Tn16 1bt |
| Contact | John Gildersleeve |
| Correspondent | Mary Dadone MARTIN,BLANK & ASSOCIATES 3905 RHODE HARBOR RD Edgewater, MD 21037 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-06 |
| Decision Date | 2015-05-27 |
| Summary: | summary |