The following data is part of a premarket notification filed by Fast Track Technologies, Inc. with the FDA for Irelieve Microcurrent Pain Relief System.
| Device ID | K212618 |
| 510k Number | K212618 |
| Device Name: | IRelieve Microcurrent Pain Relief System |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Fast Track Technologies, Inc. 4400 MacArther Blvd., Ste. 900 Newport Beach, CA 92660 |
| Contact | Geoffrey Pfeifer |
| Correspondent | Stephen Goldner Regulatory Affairs Associates, LLC. 4761 Tara Court West Bloomfield, MI 48323 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-09-14 |