FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475210458
Brand
BIOS Living
Company
Thermor Ltd
Model
LK045
Device description
Back Support Brace (Small/Medium)
Published
2023-03-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475210455PackageGS16Not in Commercial Distribution
00057475210458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521045510057475210455
00057475210458000574752104580574752104580057475210458

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Regulatory Flags#

DUNS number
246883458
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475244125BIOS DiagnosticsBD4122026-08-07
00057475000561BIOS Living59056L2023-03-31
00057475000578BIOS Living59057L2023-03-31
00057475000585BIOS Living59058L2023-03-31
00057475032500BIOS DiagnosticsW2502026-01-19
00057475160517BIOS DiagnosticsNS1602024-06-17
00057475210175BIOS LivingLK0172023-09-15
00057475210182BIOS LivingLK0182023-09-15
00057475210229BIOS LivingLK0222023-09-18
00057475210427BIOS LivingLK0422023-03-31
00057475210434BIOS LivingLK0432023-03-31
00057475210441BIOS LivingLK0442023-03-31
00057475210465BIOS LivingLK0462023-03-31
00057475210472BIOS LivingLK0472023-03-31
00057475210489BIOS LivingLK0482023-03-31
00057475211301BIOS LivingLK1302023-09-18
00057475220495BIOS Diagnostics220DI2023-09-20
00057475239497BIOS239DI2023-05-23
00057475242015BIOSBD2012022-03-04
00057475242404BIOSBD2402022-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889648CoreTechVIVE HEALTH LLCIQE2026-08-19
06979144490241Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490258Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490265Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490272Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490289Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490296Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490302Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490319Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490326Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490333Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490340Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490357Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490364Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490371Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490388Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490395Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490401Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490418Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490425Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490432Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490159Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490166Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490173Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490180Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490197Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490203Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490210Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490227Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17
06979144490234Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-17