FDA.reportPublic FDA data

POLY Pro

Primary DI
B3437000A3
Brand
POLY Pro
Company
Medtek Lighting Corporation
Model
Regen
Device description
LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using Infrared Light or Combo Red/Infrared Light to provide a feeling of General Wellness.
Published
2018-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWCGeneral Wellness Product

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWCGeneral Wellness ProductUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3437000A3PrimaryHIBCC0

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
800-882-4683info@uvbiotek.com

Regulatory Flags#

DUNS number
002692106
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
B343ML600UVBioTekMobile LiteML6002017-02-09
B3437000A1POLY7000A2017-08-31
B3437000A2Poly ProPoly Pro Rejuv2018-09-19
B3437000C1Poly Go7000C2017-09-01
B3437000C21Poly Spot7000C22017-09-01
B3437000CA1POLY GoPOLY Go Clear2018-09-17
B343B100UVBioTek100B100B2017-02-09
B343B1600UVBioTek1600B1600B2017-02-09
B343B20UVBioTek20B20B2017-02-09
B343B2400UVBioTek2400B2400B2017-02-09
B343B3200UVBioTek3200B3200B2017-02-09
B343B40UVBioTek40B40B2017-02-09
B343B4000UVBioTek4000B4000B2017-02-09
B343B60UVBioTerk60B60B2017-02-09
B343B80UVBioTek80B80B2017-02-09
B343B800UVBioTek800B800B2017-02-09
B343MD3UVBioTekMulti DirectionalMD32017-02-09
B343VL1400UVBioTekVersa-Lite 1400VL14002017-02-09
B343CT2000Peacock Tanning2000CT2000CT2017-02-09
B343CT3200Peacock Tanning3200CT3200CT2017-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978959250040Bed Wedge Pillow (7 inch)Xiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
06978959250057Big Wedge PillowXiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
06978959250118Leg Elevation Pillow (CoolingGel)Xiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
05060994740165DayeTAMPON INNOVATIONS LTD OODPWC2024-07-27
05060994740318DayeTAMPON INNOVATIONS LTD OODPWC2024-07-27
05060994741001DayeTAMPON INNOVATIONS LTD OODPWC2024-07-27
15060498452189Motion Medical DistributingHaslam Medical, Inc.PWC2022-12-29
00815948024229REAL Immersive SystemPENUMBRA, INC.PWC2021-09-14
B3437000C1Poly GoMedtek Lighting CorporationPWC2017-09-01
B3437000C21Poly SpotMedtek Lighting CorporationPWC2017-09-01