The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Drug Relief.
| Device ID | K173861 |
| 510k Number | K173861 |
| Device Name: | Drug Relief |
| Classification | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Applicant | DyAnsys, Inc. 300 North Bayshore Boulevard San Mateo, CA 94401 |
| Contact | San Mateo |
| Correspondent | San Mateo DyAnsys, Inc. 300 North Bayshore Boulevard San Mateo, CA 94401 |
| Product Code | PZR |
| CFR Regulation Number | 882.5896 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-05-02 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DRUG RELIEF 87672869 5588308 Live/Registered |
Dyansys, Inc. 2017-11-06 |