FDA.reportPublic FDA data

Baichen

Primary DI
06975185620159
Brand
Baichen
Company
NINGBO BAICHEN MEDICAL DEVICES CO., LTD
Model
Crutches
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
06975185620159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975185620159069751856201596975185620159

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
707021891
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975185620166BaichenWalking Cane2026-01-07
06975185620173BaichenBC-MS3102026-01-07
06975185620050BaichenRubicon BC-EC80022025-08-06
06975185620067BaichenRubicon BC-EA80002025-08-06
06975185620074BaichenRubicon BC-EA55162025-08-06
06975185620081BaichenRubicon BC-EC80032025-08-06
06975185620098BaichenRubicon BC-EALD32025-08-06
06975185620104BaichenSonix BC-EA8000-5302025-08-06
06975185620111BaichenSonix BC-EA55152025-08-06
06975185620128BaichenSonix BC-EA8000-90002025-08-06
06975185620135BaichenRubicon2025-08-06
06975185620142BaichenSonix2025-08-06
06975185620012BaichenBC-EA55162025-07-02
06975185620029Baichen BC-EC80022025-07-02
06975185620036BaichenBC-EC80032025-07-02
06975185620043BaichenBC-EALD32025-07-02
06975185620005BaichenBC-EA80002025-01-07

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
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
00810113574035ViveVIVE HEALTH LLCIPR2023-08-23