FDA.report

GB-3

Primary DI
14897076720146
Brand
GB-3
Company
TENS PLUS INDUSTRIAL COMPANY
Model
GD5208
Catalog number
GD5208
Device description
Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, hands, legs, knee, shoulder etc. by placing it near the surface of the bare skin (at a distance directly over the skin surface). It is effective when deep heating of body tissue is desired.
Published
2021-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications

CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14897076720146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1489707672014614897076720146

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
18007228775info@lhasaoms.com

Regulatory Flags

DUNS number
663211978
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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