FDA.reportPublic FDA data

StimQ Freedom-8A Trial Kit Channel A US w/ Receiver

Primary DI
00818225020792
Brand
StimQ Freedom-8A Trial Kit Channel A US w/ Receiver
Company
STIMWAVE TECHNOLOGIES INCORPORATED
Model
FR8A-TRL-A0
Device description
StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Trial Kit Channel A US w/ Receiver
Published
2018-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171366000Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitStimwave Technologies Inc., Dba Stimq, LLC2017-08-04GZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818225020792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818225020792008182250207928182250207920818225020792

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic implantable peripheral nerve electrical stimulation systemAn assembly of devices designed to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. It typically consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

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