FDA.reportPublic FDA data

Nalu™ User Trial Kit

Primary DI
00812537037752
Brand
Nalu™ User Trial Kit
Company
NALU MEDICAL, INC.
Model
74022
Device description
The Nalu™ User Trial Kit is comprised of one (1) externally worn Trial Therapy Disc, Charger, Wall Adapter, USB Cable and a carrying case for a trial period. The trial period is used to determine whether spinal cord stimulation or peripheral nerve stimulation, and the Nalu Neurostimulation System are appropriate for you.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00812537037752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537037752008125370377528125370377520812537037752

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporealAn electrically-powered, external (noninvasive) component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to generate electrical impulses, for wireless (transcutaneous) transmission, to an implantable lead (situated adjacent to the epidural space and/or a peripheral nerve), to relieve acute and/or chronic intractable pain (analgesia); the implantable lead is not included. It is designed for continuous therapy (i.e., not a trial therapy device). The device is programmed, controlled, and charged by external devices which may be included with the device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
067140761
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00812537037141TD2 Limb Cuff340192026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy 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.GZF2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
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.GZB2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
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.GZF2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030194Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030224Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21