FDA.reportPublic FDA data

BATTERY SYSTEM

Primary DI
05063368529106
Brand
BATTERY SYSTEM
Company
HUGH STEEPER LIMITED
Model
LITHIUM BATTERY CHARGER
Catalog number
LIBCH
Published
2023-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQZHand, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQZHand, External Limb Component, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05063368529106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05063368529106050633685291065063368529106

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric hand prosthesisA powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device features an integral or proximally mounted motor (e.g., electric, hydraulic) which actuates hand/finger movements (e.g., gripping, pinching, pointing). The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210280350
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05063368529502BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05063368529496BATTERY SYSTEM45MM KINISI SH WR HOUSINGMKSW452023-10-04
05063368529519BATTERY SYSTEM50MM KINISI SH WR HOUSING M12BBSW50-M122023-10-04
05055348200228S-CHARGES-Charger - Wall Charger KitSWC22002023-08-08
05055348200068MYO"Myoelectric Hand Quick Disconnect Wrist 6 3/4"" LMYA675LQD2023-08-04
05055348200075MYO"Myoelectric Hand Quick Disconnect Wrist 6 3/4"" RMYA675RQD2023-08-04
05055348248305MYOMyoelectric Hand Quick Disconnect Wrist 7 3/4 RighMYA775RQD2023-08-04
05055348248312MYOMyoelectric Hand Quick Disconnect Wrist 8 1/4 RighMYA825RQD2023-08-04
05056349591032MYOMYO Configuration DeviceMYO-CFG2023-08-04
05056701110802S-CHARGE3500 mAh BATTERYSC3500B2023-08-07
05055348202932MYO50MM SH WR HOUSINGBBSW502023-08-02
05055348244116MYOON/OFF SWITCH AND CHARGE PORTB278042023-08-02
05063368216198MYOSDU CONE ASSEMBLYB307002023-08-02
05055348200181ElectrodeELECTRODE CABLEECA-3002023-07-10
05055348200198ElectrodeELECTRODE CABLEECA-6002023-07-10
05055348200204ElectrodeELECTRODE CABLEECA-10002023-07-10
05055348203304Electrode50Hz ELECTRODEELEC502023-07-10
05055348203311Electrode60Hz ELECTRODEELEC602023-07-10
05055348203328ELECTRODE50Hz ELECTRODE SEAL IN KITELSK502023-07-10
05055348203335Electrode60Hz ELECTRODE SEAL IN KITELSK602023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04064411004343Myo PlusOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411004350Myo PlusOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411005524Myo Plus TROtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411005531Myo Plus TROtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411007672myosmart.Otto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008105myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008112myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008129myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008136myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411009041myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411009058myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411010856myosmart trial kitOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411013697myosmart trial kitOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411013772connectgrip.Otto Bock Healthcare Products GmbHIQZ2026-05-04
04064411014144connectgrip.Otto Bock Healthcare Products GmbHIQZ2026-05-04
08057971594702Analog Amplifier with accessoriesBIONIT LABS SRLIQZ2026-03-20
08057971594795Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594733Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-18
09421037390413TASKA PowerCore System, BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421037390420TASKA PowerCore System, SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785005TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785012TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785029TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785036TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785043TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785050TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785067TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785074TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07