FDA.reportPublic FDA data

Karma

Primary DI
04719873857227
Brand
Karma
Company
KARMA MEDICAL PRODUCTS CO., LTD.
Model
KM-1510.3
Published
2022-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K062309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062309000KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105Karma Medical Products Co., Ltd.2006-10-10IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873857227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873857227047198738572274719873857227

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, 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 manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88652066688globalsales@karma.com.tw

Regulatory Flags#

DUNS number
656291275
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873857661KarmaKS-747.21104040500372026-02-25
04719873857012KarmaKM-5000 III2022-08-03
04719873854875KarmaKM-90002022-08-03
04719873854882KarmaKM-1520.3T2022-08-03
04719873856961KarmaKM-15142022-08-03
04719873857067KarmaKM-8020IIIX, KM-8520IIIX, KM-8020IIIXHB2022-08-03
04719873857098KarmaKM-8022 II, KM-8522 II2022-08-03
04719873857128KarmaKM-8022IIS, KM-8522IIS2022-08-03
04719873857159KarmaVIP2-T, VIP2-TR2022-08-03
04719873857166KarmaKM-5000.22022-08-03
04719873857197KarmaKM-1500.3, KM-1500.42022-08-03
04719873857234KarmaKM-1520.32022-08-03
04719873857241KarmaKM-3520.22022-08-03
04719873857258KarmaKM-25012022-08-03
04719873857272KarmaKM-25122022-08-03
04719873857333KarmaKM-BT102022-08-03

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