Sparrow Therapy System

Percutaneous Nerve Stimulator For Opioid Withdrawal

Spark Biomedical, Inc.

The following data is part of a premarket notification filed by Spark Biomedical, Inc. with the FDA for Sparrow Therapy System.

Pre-market Notification Details

Device IDK201873
510k NumberK201873
Device Name:Sparrow Therapy System
ClassificationPercutaneous Nerve Stimulator For Opioid Withdrawal
Applicant Spark Biomedical, Inc. 18208 Preston Road, Suite D9-531 Dallas,  TX  75252
ContactDaniel Powell
CorrespondentMichelle Rubin-onur
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego,  CA  92110
Product CodePZR  
CFR Regulation Number882.5896 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2021-01-02

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