FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475210427
Brand
BIOS Living
Company
Thermor Ltd
Model
LK042
Device description
Adjustable Elbow Support Brace
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IOYSupport, Arm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475210424PackageGS16In Commercial Distribution
00057475210427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521042410057475210424
00057475210427000574752104270574752104270057475210427

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974500613555Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
06974500613593Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.IOY2025-10-17
00636257207710MEDIMEDI MANUFACTURING, INC.IOY2025-09-26
00636257204924MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204931MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204948MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204955MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
04823097723395"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723401"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723418"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723425"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723432"TM ""Rehabilitimed"" RP-6 M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723449"TM ""Rehabilitimed"" RP-6 L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723456"TM ""Rehabilitimed"" RP-6 XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723494"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723500"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723517"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723524"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723531"TM ""Rehabilitimed"" RP-6P M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723548"TM ""Rehabilitimed"" RP-6P L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723555"TM ""Rehabilitimed"" RP-6P XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723562"TM ""Rehabilitimed"" RP-6K-M UNI Comfort"REABILITIMED TOVIOY2025-05-17
04823097723579"TM ""Rehabilitimed"" RP-6K-M XXL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723586"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723593"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723609"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723616"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17