The following data is part of a premarket notification filed by Pierenkemper Gmbh with the FDA for Stimawell 120mtrs.
| Device ID | K181645 |
| 510k Number | K181645 |
| Device Name: | StimaWELL 120MTRS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Pierenkemper GmbH Am Geiersberg 6 Ehringshausen, DE 35630 |
| Contact | Thorsten Reichel |
| Correspondent | Andre Kindsvater Emergo Global Consulting 2500 Bee Cave Rd, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-22 |
| Decision Date | 2020-08-13 |