FDA.reportPublic FDA data

Valmax

Primary DI
00860015100467
Brand
Valmax
Company
Supply Line Medical
Model
V16K3ADAELR
Device description
"K3 16"" light weight wheelchair w/ adjustable desk-length arms and elevating footrests"
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112816000ZHENJIANG ASURE MECHANICAL WHEELCHAIRZhenjiang Assure Medical Equipment Co., Ltd.2012-04-18IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015100467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015100467008600151004678600151004670860015100467

GMDN Terms#

Term, Definition table
TermDefinition
Manual traction wheelchairA dedicated, non-powered, wheeled mobility device with a seat designed to enable occupant mobilization while facilitating spinal traction in conjunction with a skull-attached halo ring (not included) for a patient with a spinal disorder (e.g., kyphosis, scoliosis). It is designed as a push-rim wheelchair with rear-fitted handles, and a suspension frame with an overhead pulley(s) and a cable. Traction is achieved by forces from weights or springs applied to the cable connected to the halo ring. It is only intended for use in a healthcare facility, typically to stretch the spine prior to surgical correction.

Regulatory Flags#

DUNS number
117011784
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015100436ValmaxV16K2ADAELR2026-05-12
00860015100443ValmaxV18K2ADAELR2026-05-12
00860015100450ValmaxV20K2ADAELR2026-05-12
00860015100474ValmaxV18K3ADAELR2026-05-12
00860015100481ValmaxV20K3ADAELR2026-05-12
00860014621895Thrive MedicalVPTR11033680062025-12-26
00860015100412Thrive MedicalVPTR11034280062025-12-26
00860015100429Thrive MedicalVPTR11034880062025-12-26
00860014621864ValmaxVPTH11092025-12-22
00860014621871ValmaxVPTH11072025-12-22
00860015100405ValmaxDME.1842025-12-04
10860014621885ValmaxVSB482025-11-04
00860014621802ValmaxDME.0142025-09-03
00860013569846ValmaxV16K2ADAELR2025-08-26
00860013569877ValmaxVK2E202025-08-26
00860013569884ValmaxVK3E182025-08-26
00860013569891ValmaxDME.0162025-08-26
00860013569839ValmaxDME.1322025-03-20
00199284755567ValmaxDME.1322025-02-21
00860011289258ValmaxDME.0032025-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868262050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M368G1002811GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31