FDA.reportPublic FDA data

Freedom Spinal Cord Stimulator System

Primary DI
00859619004882
Brand
Freedom Spinal Cord Stimulator System
Company
STIMWAVE TECHNOLOGIES INCORPORATED
Model
FR8A-RCV-B0
Catalog number
S8R-1B US
Device description
Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel B US
Published
2016-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150517000Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2015-06-05GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859619004882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859619004882008596190048828596190048820859619004882

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation systemAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter
Outer Diameter1.35Millimeter
Weight0.25Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
078294927
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
00818225022079Stimwave Freedom Spinal Cord Stimulation System00-520162023-02-14
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