FDA.reportPublic FDA data

HCS

Primary DI
00849027000705
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS6004
Device description
Crutches Aluminum, Child, Push Button, 1 pair
Published
2020-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10849027000702PackageGS18Not in Commercial Distribution
00849027000705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700070210849027000702
00849027000705008490270007058490270007050849027000705

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)].

Regulatory Flags#

DUNS number
078572603
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849027000149HCSHCS50062017-01-17
00849027000156HCSHCS50072017-01-17
00849027002587HCSHCS5006C2017-01-17
00849027001757HCSHCS11012019-12-31
00849027001764HCSHCS1101C2019-12-31
00849027001771HCSHCS11032019-12-31
00849027001788HCSHCS1103C2019-12-31
00849027001795HCSHCS11042019-12-31
00849027001801HCSHCS11052019-12-31
00849027001818HCSHCS11062019-12-31
00849027002846HCSHCS11022019-12-31
00849027005182HCSHCS11202021-01-31
00849027005199HCSHCS1120C2021-01-31
00849027005205HCSHCS11212021-01-31
00849027005212HCSHCS11222021-01-31
00849027005229HCSHCS1122C2021-01-31
00849027005236HCSHCS11232021-01-31
00849027005243HCSHCS11252021-01-31
00849027001740HCSHCS11002019-12-31
50849027001417HCSHCS3003XL2019-12-31

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