The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Drug Relief V1.
| Device ID | K211971 |
| 510k Number | K211971 |
| Device Name: | Drug Relief V1 |
| Classification | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Applicant | DyAnsys, Inc. 300, North Bayshore Boulevard San Mateo, CA 94401 |
| Contact | Srini Nageshwar |
| Correspondent | Srini Nageshwar 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 | 2021-06-24 |
| Decision Date | 2021-11-05 |