Wearable Antenna Assembly/StimQ Wearable Antenna Gear

GUDID 00818225020822

Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear

STIMWAVE TECHNOLOGIES INCORPORATED

Multiple active implantable device programmer

• Primary Device ID: 00818225020822
• NIH Device Record Key: d42803dd-e439-45d4-bdd0-a4c365811b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wearable Antenna Assembly/StimQ Wearable Antenna Gear
• Version Model Number: PDBT-915-2K
• Company DUNS: 078294927
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818225020822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170141

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-02-05

Devices Manufactured by STIMWAVE TECHNOLOGIES INCORPORATED

• 00850051034222 - SandShark Injectable Anchor System: 2023-04-07 SandShark Injectable Anchor System
• 00818225021850 - PNS Wearable Accessory L/XL Vertical: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 00818225021867 - PNS Wearable Accessory L/XL Horizontal: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 00818225021874 - PNS Wearable Accessory S/M: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 00818225022031 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size XS Assembly
• 00818225022048 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size S Assembly
• 00818225022055 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size M Assembly
• 00818225022062 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size L Assembly