FDA.reportPublic FDA data

Karman Healthcare

Primary DI
00810058400314
Brand
Karman Healthcare
Company
KARMAN HEALTHCARE INC.
Model
PW-F500-BK
Device description
Karman Tranzit Foldable Lightweight Power Wheelchair in Black
Published
2020-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170787000Powered Wheelchair DYW30A(D09)Nanjing Jin Bai HE Medical Apparatus Co., Ltd.2017-08-09ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810058400314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810058400314008100584003148100584003140810058400314

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, occupant-controlled, manual-steering, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and manual control of direction are performed by the occupant of the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
878092667
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810058401601Karman HealthcareSLT-650HB2026-01-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198260INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198277INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198284INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198291INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198307INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198314INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198321INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198338INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198345INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198352INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198369INVACARE® 3G STORM SERIES® ARROW® POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198376INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198383INVACARE® 3G STORM SERIES® TORQUE™ SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198390INVACARE® TDX® SR POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198406INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20