Therapy Disc, Reduced Warranty 34001-002

GUDID 00812537035802

The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pulse Generator. The Therapy Disc is positioned externally over the implant using an adhesive retention clip or textile belt and may be controlled using integrated buttons or via the Nalu Remote Control Application.

NALU MEDICAL, INC.

Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 00812537035802
• NIH Device Record Key: a9c283f5-b849-4139-986a-8731ad526285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Therapy Disc, Reduced Warranty
• Version Model Number: 34001-002
• Catalog Number: 34001-002
• Company DUNS: 067140761
• Company Name: NALU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812537035802 [Primary]

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: 2026-01-27
• Device Publish Date: 2026-01-19

Devices Manufactured by NALU MEDICAL, INC.

• 00812537030234 - Therapy Disc: 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu
• 00812537032399 - Therapy Disc: 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu
• 00812537035802 - Therapy Disc, Reduced Warranty: 2026-01-27The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pulse Generator. The Therapy Disc is positioned externally over the implant using an adhesive retention clip or textile belt and may be controlled using integrated buttons or via the Nalu Remote Control Application.
• 00812537035802 - Therapy Disc, Reduced Warranty: 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu
• 00812537037134 - TD2 Therapy Disc: 2026-01-27 TD2 Therapy Disc a-la-carte
• 00812537037660 - Nalu Medical, Inc.: 2025-12-16 Trial Lead Kit (8 contact, 40 cm)
• 00812537037189 - Nalu Medical, Inc.: 2024-05-09 Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm)
• 00812537037196 - Nalu Medical, Inc.: 2024-05-09 Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
• 00812537037202 - Nalu Medical, Inc.: 2024-05-09 Lead Kit (8 contact, 40 cm)