FDA.reportPublic FDA data

Forearm Crutches - Tall, 5'10" - 6'6"

Primary DI
00616784011219
Brand
Forearm Crutches - Tall, 5'10" - 6'6"
Company
Dynarex Corporation
Model
10112
Published
2019-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00840117341500PackageGS11In Commercial Distribution
00616784011219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117341500008401173415008401173415000840117341500
00616784011219006167840112196167840112190616784011219

GMDN Terms#

Term, Definition table
TermDefinition
Forearm support crutchA staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one or more legs and a padded support or "trough" in a horizontal position for the user to rest the forearm. The hand wraps around a grip at the end of the forearm support. The device may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is particularly suited to individuals who cannot rest their weight on their hands.

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01
00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979977310020TMCCEShen Zhen Shi Fan Fen Shu Technology Co., Ltd.IPR2026-08-21
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