FDA.reportPublic FDA data

Therapy Disc

Primary DI
00812537032399
Brand
Therapy Disc
Company
NALU MEDICAL, INC.
Model
34001-001
Catalog number
34001-001
Device description
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.
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812537032399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537032399008125370323998125370323990812537032399

GMDN Terms#

Term, Definition table
TermDefinition
Implantable spinal cord electrical stimulation system programmerA battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure80 KiloPascal107 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-618-3402info@nalumed.com

Regulatory Flags#

DUNS number
067140761
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812537037752Nalu™ User Trial Kit740222026-05-27
10812537030125Nalu Medical, Inc.23002-065-US23002-065-US2020-04-21
10812537030194Nalu Medical, Inc.23012-030-US23012-030-US2020-04-21
10812537030200Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
10812537030217Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
00812537030203Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
00812537030210Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
00812537030227Nalu Medical, Inc.23013-050-US23013-050-US2020-04-21
00812537030487Nalu Medical, Inc.71001-US71001-US2020-04-21
00812537030494Nalu Medical, Inc.71002-US71002-US2020-04-21
00812537030791Nalu Medical, Inc.71006-US71006-US2020-04-21
00812537032252Nalu Medical, Inc.23012-030-US23012-030-US2020-04-21
00812537032894Nalu Medical, Inc.71010-US71010-US2020-04-21
00812537033471Nalu Medical, Inc.71001-US71001-US2020-04-21
00812537033488Nalu Medical, Inc.71002-US71002-US2020-04-21
00812537035260Nalu Medical, Inc.23002-045-US23002-045-US2020-04-21
00812537035345Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
00812537035352Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
00812537035505Nalu Medical, Inc.71006-US71006-US2020-04-21
00812537035529Nalu Medical, Inc.71010-US71010-US2020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537037752Nalu™ User Trial KitNALU MEDICAL, INC.GZF2026-05-27
00812537037752Nalu™ User Trial KitNALU MEDICAL, INC.GZB2026-05-27
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030194Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21