FDA.reportPublic FDA data

Nerve Reviver

Primary DI
00860011592815
Brand
Nerve Reviver
Company
Protocol Solutions LLC
Model
Neurowave
Device description
Infrared therapeutic heating device marketed under the Nerve Reviver brand. Neurowave model provides non-invasive infrared light therapy intended for temporary relief of minor muscle and joint pain, stiffness, and increased local circulation.
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011592815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011592815008600115928158600115928150860011592815

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
417-593-7725myprotocolsolutions@gmail.com

Regulatory Flags#

DUNS number
128815621
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011592839Nerve ReviverNeuroglow2025-09-18
00860011592808Protocol SolutionsNerve Care +2025-09-05
00869911592802Protocol SolutionsNerve Care +2024-03-26

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Primary DI, Brand, Company table
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