510(k) K173861
- Device
- Drug Relief
- Applicant
- DyAnsys, Inc.
- 510(k) number
- K173861
- Product code
- PZR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-02
- Date received
- 2017-12-20
- Regulation
- 882.5896
- Classification name
- Percutaneous Nerve Stimulator For Opioid Withdrawal
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- San Mateo
- Address
- 300, N. Bayshore Blvd. San Mateo CA US 94401 94401
FDA Registration Numbers#
- 3010350335
- 3017987352
- 3008255748
- 3011743372
- 3039168176
- 3014122529
Source Documents#
Other 510(k) Records For Product Code PZR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251246 | Sparrow Ascent | Spark Biomedical, Inc. | 2025-08-25 |
| K233166 | NET Recovery Corp/NET Device | Net Recovery | 2024-05-29 |
| K230796 | Sparrow Ascent | Spark Biomedical, Inc. | 2023-06-20 |
| K221231 | Drug Relief v1 | Dyansys, Inc. | 2022-06-06 |
| K211971 | Drug Relief v1 | Dyansys, Inc. | 2021-11-05 |
| K201873 | Sparrow Therapy System | Spark Biomedical, Inc. | 2021-01-02 |
| DEN170018 | NSS-2 System | Innovative Health Solutions (Ihs), Inc. | 2017-11-15 |
Legacy Summary#
summary
FDA Review#
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