FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475210434
Brand
BIOS Living
Company
Thermor Ltd
Model
LK043
Device description
Adjustable Knee Support Brace
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
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475210431PackageGS16Not in Commercial Distribution
00057475210434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521043110057475210431
00057475210434000574752104340574752104340057475210434

GMDN Terms#

Term, Definition table
TermDefinition
Knee support orthosisA stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. 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
00057475700324BIOS Living700322023-11-07
00057475800130BIOS Living800132023-11-06
00060476327049BIOS327042022-03-04
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
00057475210441BIOS LivingLK0442023-03-31
00057475210458BIOS LivingLK0452023-03-31
00057475210465BIOS LivingLK0462023-03-31
00057475210472BIOS LivingLK0472023-03-31
00057475210489BIOS LivingLK0482023-03-31
00057475211301BIOS LivingLK1302023-09-18
00057475220495BIOS Diagnostics220DI2023-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441538ViveVIVE HEALTH LLCITQ2026-08-03
00049696508377THERA PlusFOURSTAR GROUP INC.ITQ2026-06-09
00810178889280CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889297CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889303CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889310CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889327CoreTechVIVE HEALTH LLCITQ2026-05-05
0060927120013516'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610842"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610859"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610866"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08