Freedom Spinal Cord Stimulator (SCS) System— 510(k) K182720

Clearance details

Applicant

Stimwave Technologies Incorporated

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

2018-09-28

Decision date

2019-03-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pompano Beach, FL, US

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• K221376 — Nalu Neurostimulation System2022-06-10
• K203547 — Nalu Neurostimulation System2021-03-25
• K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits2020-11-09
• K201618 — Nalu Neurostimulation SCS system2020-07-15

• K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit2018-09-19
• K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base2017-11-03
• K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit2017-05-02
• K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit2016-12-16
• K160600 — Freedom Spinal Cord Stimulator System2016-08-26

Death

4

Injury

1,879

Other

2

Total

1,885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →