Atlas FDA

StimQ Peripheral Nerve Stimulator (PNS) System

FDA 510(k) clearance K152178 · decided 2016-03-11

Clearance details

K-number
K152178
Device name
StimQ Peripheral Nerve Stimulator (PNS) System
Applicant
Stimq, LLC
Decision
Substantially Equivalent
Date received
2015-08-04
Decision date
2016-03-11
Days to decision
220 days
Clearance type
Traditional
Product code
GZF
Device class
2
Regulation number
882.5870
Medical specialty
Neurology
Advisory committee
Neurology
Location
Fort Lauderdale, FL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 E recall (Z-2928-2020)Stimwave Technologies Inc2020-09-02
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is us recall (Z-2929-2020)Stimwave Technologies Inc2020-09-02
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO recall (Z-2930-2020)Stimwave Technologies Inc2020-09-02
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is u recall (Z-2931-2020)Stimwave Technologies Inc2020-09-02
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is us recall (Z-2932-2020)Stimwave Technologies Inc2020-09-02
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A recall (Z-2933-2020)Stimwave Technologies Inc2020-09-02