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Percutaneous Nerve Stimulator For Opioid Withdrawal

FDA product code PZR · Class 2 · Neurology

18
Registered devices
0
Adverse events
1
Recalls
8
510(k) clearances

Devices with this code

Sparrow Ascent Kit (B2B) — Spark Biomedical Inc.Sparrow Ascent Earpiece, Right — Spark Biomedical Inc.Morph Device — DYANSYS INDIA PRIVATE LIMITEDSparrow Ascent Replacement Kit — Spark Biomedical Inc.Sparrow Ascent Kit (B2C) — Spark Biomedical Inc.Sparrow Ascent Cable — Spark Biomedical Inc.NSS-2 — KEY ELECTRONICS, INC.Sparrow Ascent — Spark Biomedical Inc.S.T. Genesis — DYANSYS INDIA PRIVATE LIMITEDDrug Relief v1 — DYANSYS INDIA PRIVATE LIMITEDSparrow Ascent Earpiece, Left — Spark Biomedical Inc.Sparrow Ascent 28 Piece Kit (B2B) — Spark Biomedical Inc.Sparrow Ascent Patient Controller — Spark Biomedical Inc.NSS-2 Bridge — Neuraxis, Inc.Sparrow Ascent Cable — Spark Biomedical Inc.Sparrow Ascent 28 Piece Kit (B2C) — Spark Biomedical Inc.OpiEase — DYANSYS INDIA PRIVATE LIMITEDOpiRelief — DYANSYS INDIA PRIVATE LIMITED

Recent recalls

DateFirmReason
2025-07-02Spark Biomedical IncDue to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.