PNS Wearable Accessory L/XL Vertical 00-52002

GUDID 00818225021850

Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.

STIMWAVE TECHNOLOGIES INCORPORATED

Personal device holder, reusable

• Primary Device ID: 00818225021850
• NIH Device Record Key: 813cfd6a-3e04-4d2d-a975-25c1af0a8896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNS Wearable Accessory L/XL Vertical
• Version Model Number: 00-52002
• Catalog Number: 00-52002
• Company DUNS: 078294927
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818225021850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182720

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-22
• Device Publish Date: 2023-02-14

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: 2023-02-22Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 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