FDA.reportPublic FDA data

Collagentex Series

Primary DI
00850056256414
Brand
Collagentex Series
Company
Tanses Technologies Inc
Model
RX-1-Seat
Device description
Collagentex Rx-1-Seat NIR device, Seat version, model Rx-1-Seat, 1 lamp module
Published
2023-10-16
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056256414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056256414008500562564148500562564140850056256414

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
450-622-4004info@collagentex.com

Regulatory Flags#

DUNS number
253238190
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056256124Tanses T-32 SeriesTx-32-2002023-10-26
00850056256131Tanses T-32 SeriesTX-32-F2023-10-26
00850056256148Tanses T-32 SeriesTX-32-2F2023-10-26
00850056256155Tanses T-32 SeriesTX-32-3F2023-10-26
00850056256162Tanses T-32 SeriesTX-32-160-F2023-10-26
00850056256179Tanses T-32 SeriesTx-32-160-2F2023-10-26
00850056256186Tanses T-32 SeriesTX-32-160-3F2023-10-26
00850056256193Tanses T-32 SeriesTx-32-200-3F2023-10-26
00850056256254Tanses T-40 SeriesT-402023-10-26
00850056256261Tanses T-40 SeriesT-40-F2023-10-26
00850056256278Tanses T-40 SeriesT-40-3F2023-10-26
00850056256285Tanses T-44 Series Tx-442023-10-26
00850056256292Tanses T-44 SeriesTx-44-3F2023-10-26
00850056256308Tanses T-52 SeriesT-522023-10-26
00850056256315Tanses T-52 SeriesT-52-M2023-10-26
00850056256322Tanses T-52 SeriesT-52-M-F2023-10-26
00850056256339Tanses T-52 SeriesT-52-M-3F2023-10-26
00850056256346Tanses T-72 SeriesT-722023-10-26
00850056256353Tanses T-72 SeriesVector-3F2023-10-26
00850056256018Tanses T-32 SeriesT-32-1602023-10-17

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