FDA.reportPublic FDA data

Pure Enrichment

Primary DI
00817387029179
Brand
Pure Enrichment
Company
BEAR DOWN CONSULTING
Model
PECAIR24-G
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817387029179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817387029179008173870291798173870291790817387029179

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040869867
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853975005675Pure EnrichmentPEGELPAK2023-04-07
B311PEBRPUMP0PURE ENRICHMENTPEBRPUMP2018-12-03
00810115635185Pure EnrichmentPEHUTRB2G-W2025-09-08
B311PEPULSERT0PURE ENRICHMENTPEPULSE-RT2022-07-22
00810115633235VeriluxVT54WW62024-10-07
00768533810007VeriluxVT20WW12024-09-22
00810115633280Pure EnrichmentPEHPWD2-PE2024-08-28
B311PETNHTPR0PURE ENRICHMENTPETNHTPR2023-12-15
B311PETNHTPR1PURE ENRICHMENTPETNHTPR2023-12-15
B311PEHTNPDS20PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS50PURE ENRICHMENTPEHTNPDS52023-12-14
B311PEHTNPDS21PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS51PURE ENRICHMENTPEHTNPDS52023-12-14
00768533140043VeriluxVT32WW32023-05-17
00768533140050VeriluxVT31WW32023-05-17
00768533140067VeriluxVT43WW32023-05-17
00768533140098VeriluxVT42WW32023-05-17
00768533140104VeriluxVT52WW32023-05-17
00817387024228VeriluxVT37WW12023-05-17
00817387025799VeriluxVT43MB32023-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12