FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475210465
Brand
BIOS Living
Company
Thermor Ltd
Model
LK046
Device description
Back Support Brace (Large/X-Large)
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
10057475210462PackageGS16Not in Commercial Distribution
00057475210465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521046210057475210462
00057475210465000574752104650574752104650057475210465

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
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
00057475210458BIOS LivingLK0452023-03-31
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
00057475242527BIOSBD2522023-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776102321Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102338Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102345Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102352Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102369Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102376Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103366Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103373Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103380Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103397Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103403Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103410Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106046Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106053Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106060Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106077Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106084Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106091Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106107Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106114Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106121Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106138Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106145Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106152Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106169Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106176Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106244Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106251Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106268Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106275Neotech CareNEOTECH CARE INC.IQE2026-07-23