FDA.reportPublic FDA data

Nerve Reviver

Primary DI
00860011592839
Brand
Nerve Reviver
Company
Protocol Solutions LLC
Model
Neuroglow
Device description
The Nerve Reviver Neuroglow Wrap delivers soothing infrared light therapy through a flexible, comfortable design that contours to the body. Using therapeutic infrared LED technology, it helps relax muscles, ease minor aches and stiffness, and support healthy circulation. Portable, reusable, and easy to clean, Neuroglow provides safe, non-invasive relief that can be used at home, in clinics, or on the go.
Published
2025-09-18
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
00860011592839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011592839008600115928398600115928390860011592839

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
4175937725myprotocolsolutions@gmail.com

Regulatory Flags#

DUNS number
128815621
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011592815Nerve ReviverNeurowave2025-09-17
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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08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
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00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
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