FDA.reportPublic FDA data

ULTRABEAM

Primary DI
00850080467015
Brand
ULTRABEAM
Company
ULTRA PAIN PRODUCTS INC
Model
UBH-0027
Device description
Red/infrared light phototherapy unit for the hand/wrist
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850080467015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080467015008500804670158500804670150850080467015

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(833) 268-4724info@ultrapainpro.com

Regulatory Flags#

DUNS number
064121191
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080467077ULTRAICEUIB-00402026-04-09
00850080467084ULTRAICEUIK-00302026-04-09
00850080467091ULTRAICEUIS-00602026-04-09
00850080467107ULTRAICEUIS-00502026-04-09
00850080467114ULTRAICEUIA-00702026-04-09
00850080467121ULTRAICEUIC-00802026-04-09
00850080467022ULTRABEAMUBC-00282026-01-08
00850080467039ULTRABEAMUBL-00262026-01-08
00850080467046ULTRABEAMUBK-00242026-01-08
00850080467053ULTRABEAMUBS-00252026-01-08

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Primary DI, Brand, Company table
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