Drug Relief V1

Percutaneous Nerve Stimulator For Opioid Withdrawal

DyAnsys, Inc.

The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Drug Relief V1.

Pre-market Notification Details

Device IDK211971
510k NumberK211971
Device Name:Drug Relief V1
ClassificationPercutaneous Nerve Stimulator For Opioid Withdrawal
Applicant DyAnsys, Inc. 300, North Bayshore Boulevard San Mateo,  CA  94401
ContactSrini Nageshwar
CorrespondentSrini Nageshwar
DyAnsys, Inc. 300, North Bayshore Boulevard San Mateo,  CA  94401
Product CodePZR  
CFR Regulation Number882.5896 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-24
Decision Date2021-11-05

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