FDA.reportPublic FDA data

BIOS Living

Primary DI
10057475060357
Brand
BIOS Living
Company
Thermor Ltd
Model
56035
Device description
Aluminum Crutches - Large
Published
2023-03-31
Public version status
New
Distribution status
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
IPRCrutch

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475060357PackageGS112In Commercial Distribution
00057475560355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747506035710057475060357
00057475560355000574755603550574755603550057475560355

GMDN Terms#

Term, Definition table
TermDefinition
Axillary crutchA staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)].

Sterilization Methods#

Method table
Method

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
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
00199536930124BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930131BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930148BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930155BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930162BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
00199536930179BluelineTransparent Supply Solutions Ltd.IPR2026-05-15
06975185620159BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDIPR2026-01-07
06972223254703CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254710CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254727CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254734CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254697CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-11
06972855535065Adjustable Aluminum CrutchesJiangsu Jumao X-Care Medical Equipment Co.,LtdIPR2025-07-08
06950715505571cofoeCofoe Medical Technology Co.,LtdIPR2024-12-09
00850632007980True Comfort Quad CaneHOME AIDE DIAGNOSTICS, INC.IPR2024-10-08
10850632007987True Comfort Quad CaneHOME AIDE DIAGNOSTICS, INC.IPR2024-10-08
00818323020441VIVEVIVE HEALTH LLCIPR2024-05-01
10818323020448VIVEVIVE HEALTH LLCIPR2024-05-01
00860009370609Medzah Aluminum Crutches SmallMedzah IndustriesIPR2024-01-23
00860009370616Medzah Aluminum Crutches MediumMedzah IndustriesIPR2024-01-23
00860009370623Medzah Aluminum Crutches TallMedzah IndustriesIPR2024-01-23
10860009370606Medzah Aluminum Crutches SmallMedzah IndustriesIPR2024-01-23
10860009370613Medzah Aluminum Crutches MediumMedzah IndustriesIPR2024-01-23
10860009370620Medzah Aluminum Crutches TallMedzah IndustriesIPR2024-01-23
00810113574813VIVEVIVE HEALTH LLCIPR2023-11-13
00810113574820VIVEVIVE HEALTH LLCIPR2023-11-13
10810113574810VIVEVIVE HEALTH LLCIPR2023-11-13
10810113574827VIVEVIVE HEALTH LLCIPR2023-11-13
06940979190033LUYAOZhejiang Luyao Electronics Technology Co., Ltd.IPR2023-08-29
00810113574028ViveVIVE HEALTH LLCIPR2023-08-23