FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475210489
Brand
BIOS Living
Company
Thermor Ltd
Model
LK048
Device description
Adjustable Ankle 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
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475210486PackageGS16Not in Commercial Distribution
00057475210489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521048610057475210486
00057475210489000574752104890574752104890057475210489

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. 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
00057475210458BIOS LivingLK0452023-03-31
00057475210465BIOS LivingLK0462023-03-31
00057475210472BIOS LivingLK0472023-03-31
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
00810226440593CoreTechVIVE HEALTH LLCITW2026-07-16
00049696508384THERA PlusFOURSTAR GROUP INC.ITW2026-06-09
00810178889723ViveVIVE HEALTH LLCITW2026-05-27
00810178889730ViveVIVE HEALTH LLCITW2026-05-27
00810178889747ViveVIVE HEALTH LLCITW2026-05-27
00810178889754ViveVIVE HEALTH LLCITW2026-05-27
00810178889761ViveVIVE HEALTH LLCITW2026-05-27
00810178889778ViveVIVE HEALTH LLCITW2026-05-27
00810178889785ViveVIVE HEALTH LLCITW2026-05-27
00810178889792ViveVIVE HEALTH LLCITW2026-05-27
00810178889808ViveVIVE HEALTH LLCITW2026-05-27
00810178889815ViveVIVE HEALTH LLCITW2026-05-27
00810178889822ViveVIVE HEALTH LLCITW2026-05-27
00810178889839ViveVIVE HEALTH LLCITW2026-05-27
00810178889846ViveVIVE HEALTH LLCITW2026-05-27
00810178889853ViveVIVE HEALTH LLCITW2026-05-27
00810178889860ViveVIVE HEALTH LLCITW2026-05-27
00810178889877ViveVIVE HEALTH LLCITW2026-05-27
00810178889884ViveVIVE HEALTH LLCITW2026-05-27
00810178889891ViveVIVE HEALTH LLCITW2026-05-27
00810178889907ViveVIVE HEALTH LLCITW2026-05-27
00810178889914ViveVIVE HEALTH LLCITW2026-05-27
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24