FDA.reportPublic FDA data

Karman Healthcare

Primary DI
00810058401601
Brand
Karman Healthcare
Company
KARMAN HEALTHCARE INC.
Model
SLT-650HB
Device description
Ultra Lightweight Wheelchair with swing away footrest, attendant brakes and anti-tippers
Published
2026-01-19
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
00810058401601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810058401601008100584016018100584016010810058401601

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
878092667
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810058401618Karman HealthcareSLT-6502026-01-19
00810058401588Karman Healthcare OT102024-06-28
00810058400321Karman Healthcare K2024-01-09
00810058400345Karman Healthcare M2024-01-09
00810058401571Karman Healthcare LT-5552024-01-09
00810058400123Karman Healthcare 802-DY2022-10-28
00810058400130Karman Healthcare 802N-DY2022-10-28
00810058401311Karman Healthcare LT-990-BK2022-10-28
00810058401328Karman Healthcare LT-980-BK2022-10-28
00810058401335Karman Healthcare LT-980-BD2022-10-28
00810058401342Karman Healthcare LT-980-SI2022-10-28
00810058401359Karman Healthcare KN-880-E2022-10-28
00810058401397Karman Healthcare LT-800T2022-10-28
00810058401403Karman Healthcare LT-700NT2022-10-28
00810058401410Karman Healthcare KN-700T2022-10-28
00810058401427Karman Healthcare KN-700NT2022-10-28
00810058401434Karman Healthcare LT-800NT2022-10-28
00810058401441Karman Healthcare LT-700T-20W2022-10-28
00810058401458Karman Healthcare LT-770Q2022-10-28
00810058401465Karman Healthcare LT-K52022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
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