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510(k) K221231

Drug Relief v1 by Dyansys, Inc. — Product Code PZR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 6, 2022
Date Received: April 29, 2022
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class: Class II
Regulation Number: 882.5896
Review Panel: NE
Submission Type

Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.

Other clearances by Dyansys, Inc.

K221425 — Primary Relief (September 13, 2022)
K220397 — ANSiStim-PP (May 12, 2022)
K213188 — Primary Relief (January 31, 2022)
K212859 — First Relief (December 20, 2021)
K211971 — Drug Relief v1 (November 5, 2021)
K202940 — First Relief v1 (December 29, 2020)
K173861 — Drug Relief (May 2, 2018)
K170391 — ANSiStim-PP (March 9, 2017)
K141168 — ANSISTIM (May 15, 2015)
K091397 — ECSCOPE 200 (July 8, 2009)