FDA.reportPublic FDA data

Stimwave Freedom Spinal Cord Stimulation System

Primary DI
00818225022079
Brand
Stimwave Freedom Spinal Cord Stimulation System
Company
STIMWAVE TECHNOLOGIES INCORPORATED
Model
00-52016
Device description
Torso Belt Size XL Assembly
Published
2023-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182720000Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated2019-03-29GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818225022079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818225022079008182250220798182250220790818225022079

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078294927
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818225021850PNS Wearable Accessory L/XL Vertical00-5200200-520022023-02-14
00818225021867PNS Wearable Accessory L/XL Horizontal00-520032023-02-14
00818225021874PNS Wearable Accessory S/M00-520042023-02-14
00818225022031Stimwave Freedom Spinal Cord Stimulation System00-520182023-02-14
00818225022048Stimwave Freedom Spinal Cord Stimulation System00-520132023-02-14
00818225022055Stimwave Freedom Spinal Cord Stimulation System00-520142023-02-14
00818225022062Stimwave Freedom Spinal Cord Stimulation System00-520152023-02-14
00818225022086Stimwave Freedom Spinal Cord Stimulation System00-520172023-02-14
00818225020846StimQ SWAG Accessory Kit Upper ArmMD03472018-02-05
00818225020853StimQ SWAG Accessory Kit Lower ArmMD03462018-02-05
00818225020860StimQ SWAG Accessory Kit TorsoMD03452018-02-05
00818225020877StimQ SWAG Accessory Kit Upper LegMD03442018-02-05
00818225020884StimQ SWAG Accessory Kit Lower LegMD03392018-02-05
00850051034222SandShark Injectable Anchor SystemSHRK-ALL-1K-US2023-03-30
00818225020150Wearable Antenna AssemblyPDBT-915-2K2018-10-25
00818225020334"Small Antenna 12"" Length"MD0725-12-SS2018-10-25
00818225020525"Small Antenna 27"" Length"MD0725-27-SS2018-10-25
00818225020532"SeaSilk Antenna Large 28"" Length"MD0742-28-SS2018-10-25
00818225020549"SeaSilk Antenna Small 27"" Length"MD0812-27-SS2018-10-25
00818225020556"SeaSilk Antenna Small 12"" Length"MD0812-12-SS2018-10-25

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