Drug Relief v1
FDA 510(k) K211971 · Dyansys, Inc.
510(k) numberK211971
Submission
- Device name
- Drug Relief v1
- Applicant
- Dyansys, Inc.
San Mateo, CA, US - Received
- June 24, 2021
- Decision date
- November 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code PZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251246 | Sparrow AscentPZR · Traditional | Spark Biomedical, Inc. | 08/25/2025SE |
| K233166 | NET Recovery Corp/NET DevicePZR · Traditional | Net Recovery | 05/29/2024SE |
| K230796 | Sparrow AscentPZR · Traditional | Spark Biomedical, Inc. | 06/20/2023SE |
| K221231 | Drug Relief v1PZR · Special | Dyansys, Inc. | 06/06/2022SE |
| K201873 | Sparrow Therapy SystemPZR · Traditional | Spark Biomedical, Inc. | 01/02/2021SE |
| K173861 | Drug ReliefPZR · Traditional | Dyansys, Inc. | 05/02/2018SE |
More from Dyansys, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221425 | Primary ReliefNHI · Traditional | 09/13/2022SE |
| K221231 | Drug Relief v1PZR · Special | 06/06/2022SE |
| K220397 | ANSiStim-PPNHI · Traditional | 05/12/2022SE |
| K213188 | Primary ReliefNHI · Traditional | 01/31/2022SE |
| K212859 | First ReliefNHI · Traditional | 12/20/2021SE |
| K202940 | First Relief v1QHH · Traditional | 12/29/2020SE |
| K173861 | Drug ReliefPZR · Traditional | 05/02/2018SE |
| K170391 | ANSiStim-PPBWK · Special | 03/09/2017SE |
| K141168 | AnsistimBWK · Traditional | 05/15/2015SE |
| K091397 | Ecscope 200DPS · Traditional | 07/08/2009SE |
Questions and answers
When was Drug Relief v1 cleared by the FDA?
Drug Relief v1 (K211971) received a 510(k) decision of Substantially Equivalent on November 5, 2021, 134 days after the submission was received.
What is the product code of K211971?
The FDA product code is PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal, a Class II (moderate risk) device regulated under 21 CFR 882.5896.