FDA.reportPublic FDA data

TMCCE

Primary DI
06979977310020
Brand
TMCCE
Company
Shen Zhen Shi Fan Fen Shu Technology Co., Ltd.
Model
Pro
Device description
Hands-free knee crutch for mobility assistance, designed for non-weight bearing lower leg injuries, providing hands-free and pain-free mobility.
Published
2026-08-21
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
06979977310020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979977310020069799773100206979977310020

GMDN Terms#

Term, Definition table
TermDefinition
Single-side-support walking frameA mobility aid in the form of a waist-high framework and a handgrip with two legs designed to provide a stable support to only one side of the user, e.g., a person with a disability, a geriatric or an infirm person; it may also be used during rehabilitation. It is typically constructed of lightweight metal, plastic and rubber materials in the shape of an "A" or and inverted "U" frame with a cross-strut or struts that keep the two feet apart providing stable contact with the ground. It is held by the user's hand to provide an optional form of support for standing and ambulating for a user needing more support than that provided by a walking stick (a cane) and who do not require a crutch.

Regulatory Flags#

DUNS number
452342510
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
06979977310013ThreemartPro2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"Dynarex CorporationIPR2026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"Dynarex CorporationIPR2026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"Dynarex CorporationIPR2026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"Dynarex CorporationIPR2026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"Dynarex CorporationIPR2026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"Dynarex CorporationIPR2026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"Dynarex CorporationIPR2026-07-31
06979977310013ThreemartShen Zhen Shi Fan Fen Shu Technology Co., Ltd.IPR2026-06-10
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