FDA.reportPublic FDA data

Pain-x-2000

Primary DI
00865198000320
Brand
Pain-x-2000
Company
DIOMEDICS LIGHT THERAPY INC
Model
Model 1600
Device description
Infrared Heating Device
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982546000PHASER-2000Diomedics, Inc.1998-09-22ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865198000320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865198000320008651980003208651980003200865198000320

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable mains electricity (AC-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, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). It is normally available [non-prescription] over-the-counter (OTC) for use by the patient in the home or by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-4699info@diomedics.com

Regulatory Flags#

DUNS number
799055483
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865198000306Pain-x-2000Therapy Boot system2017-01-06
00865198000313Pain-x-2000Infrabed2017-01-06

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Primary DI, Brand, Company table
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