Atlas FDA

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k) clearance K171366 · decided 2017-08-04

Clearance details

K-number
K171366
Device name
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
Applicant
Stimwave Technologies Inc., Dba Stimq, LLC
Decision
Substantially Equivalent
Date received
2017-05-09
Decision date
2017-08-04
Days to decision
87 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