FDA.reportPublic FDA data

Yang Guang TDP Lamp

Primary DI
00831592003991
Brand
Yang Guang TDP Lamp
Company
UPC MEDICAL SUPPLIES, INC.
Model
CQG-222A/G-1C
Device description
Yang Guang brand TDP Lamp is one of the most reliable and durable far infrared mineral lamps in the U.S.
Published
2016-09-23
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020851000TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222DC&H International2002-09-23ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00831592003991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831592003991008315920039918315920039910831592003991

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Length33Inch
Weight21Pound
Width11Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942011719
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00831592001027Kingli Single Acupuncture NeedleA-1K 0.40 X 502016-09-23
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00831592001096Kingli Single Acupuncture NeedleA-1K 0.35 X 1252016-09-23
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00831592001140Kingli Single Acupuncture NeedleA-1K 0.30 X 502016-09-23
00831592001157Kingli Single Acupuncture NeedleA-1K 0.30 X 602016-09-23
00831592001164Kingli Single Acupuncture NeedleA-1K 0.30 X 752016-09-23
00831592001171Kingli Single Acupuncture NeedleA-1K 0.30 X 1002016-09-23
00831592001188Kingli Single Acupuncture NeedleA-1K 0.30 X 1252016-09-23

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