FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475590888
Brand
BIOS Living
Company
Thermor Ltd
Model
59088
Device description
Acupressure Mat and Pillow Set
Published
2023-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LYGMassager, Therapeutic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475590885PackageGS16In Commercial Distribution
00057475590888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747559088510057475590885
00057475590888000574755908880574755908880057475590888

GMDN Terms#

Term, Definition table
TermDefinition
Acupressure applicator, reusableA small device intended for the application of noninvasive, non-powered acupressure to acupuncture points on the skin for the treatment of a variety of conditions/disorders. It is made of polymer materials and is supplied in a variety of shapes and sizes with differently shaped contact points; it is typically held on the skin with slight manual pressure. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

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Primary DI, Brand, Company table
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00754028803302Fascia Buddy Silicone Cups - Lite - Small Eastern Currents Distributing LtdLYG2025-08-15
00754028803401Fascia Buddy Silicone Cups - Lite - Extra Small Eastern Currents Distributing LtdLYG2025-08-15
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00754028821719Fascia Buddy Silicone Cups - MediumEastern Currents Distributing LtdLYG2025-08-15
00754028821818Fascia Buddy Silicone Cups - SmallEastern Currents Distributing LtdLYG2025-08-15
00754028821917Fascia Buddy Silicone Cups- Extra SmallEastern Currents Distributing LtdLYG2025-08-15
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00754028871011Fascia Buddy Square Cup - Extra Large Eastern Currents Distributing LtdLYG2025-08-15
00754028872025Fascia Buddy Square Cup - Large Eastern Currents Distributing LtdLYG2025-08-15
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00754028874043Fascia Buddy Square Cup - Small Eastern Currents Distributing LtdLYG2025-08-15
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08052464700158Tesmed CELLULITEFELDI SRLLYG2025-05-14
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00073950339230WaterPik Caddy Buddy with PowerPulseWATER PIK, INC.LYG2025-01-29
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