The following data is part of a premarket notification filed by Carol Cole Company with the FDA for Trinity Ele.
| Device ID | K131251 |
| 510k Number | K131251 |
| Device Name: | TRINITY ELE |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carol Cole Company 1325 Sycamore Ave Ste A Vista, CA 92081 |
| Contact | Rand Daoud |
| Correspondent | Rand Daoud Carol Cole Company 1325 Sycamore Ave Ste A Vista, CA 92081 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810075940206 | K131251 | 000 |
| 00810075940183 | K131251 | 000 |