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510(k) K170141

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit by Stimwave Technologies Incorporated — Product Code GZB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 2, 2017
Date Received: January 17, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class: Class II
Regulation Number: 882.5880
Review Panel: NE
Submission Type

Other clearances by Stimwave Technologies Incorporated

K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (September 19, 2018)
K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, (November 3, 2017)
K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna (December 16, 2016)
K160600 — Freedom Spinal Cord Stimulator System (August 26, 2016)
K150517 — Freedom Spinal Cord Stimulator System (June 5, 2015)
K141399 — FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM (October 10, 2014)

Other clearances for product code GZB

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K221376 — Nalu Neurostimulation System (June 10, 2022)
K203547 — Nalu Neurostimulation System (March 25, 2021)
K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula (November 9, 2020)
K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
K191466 — SandShark Injectable Anchor (SIA) System (November 7, 2019)
K190960 — Nalu Lead Blank (50cm) (July 11, 2019)
K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
K183047 — Nalu Neurostimulation System (March 22, 2019)
K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (September 19, 2018)