FDA.reportPublic FDA data

TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD Sand

Primary DI
09421906785111
Brand
TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD Sand
Company
TASKA PROSTHETICS LIMITED
Model
TASKA-B2FC21-U1
Published
2026-01-07
Public version status
New
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
09421906785111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421906785111094219067851119421906785111

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
594832527
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421037390413TASKA PowerCore System, BlackTASKA-21AB312026-01-07
09421037390420TASKA PowerCore System, SandTASKA-21AC312026-01-07
09421906785005TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP WhiteTASKA-B1CA21-U12026-01-07
09421906785012TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP BlackTASKA-B1CB21-U12026-01-07
09421906785029TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP SandTASKA-B1CC21-U12026-01-07
09421906785036TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD WhiteTASKA-B1FA21-U12026-01-07
09421906785043TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD BlackTASKA-B1FB21-U12026-01-07
09421906785050TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD SandTASKA-B1FC21-U12026-01-07
09421906785067TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP WhiteTASKA-B2CA21-U12026-01-07
09421906785074TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP BlackTASKA-B2CB21-U12026-01-07
09421906785081TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP SandTASKA-B2CC21-U12026-01-07
09421906785098TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD WhiteTASKA-B2FA21-U12026-01-07
09421906785104TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD BlackTASKA-B2FB21-U12026-01-07
09421906785128TASKA HandGen2 Myoelectric Hand - 7 3/4 RH LP WhiteTASKA-C1CA21-U12026-01-07
09421906785135TASKA HandGen2 Myoelectric Hand - 7 3/4 RH LP BlackTASKA-C1CB21-U12026-01-07
09421906785142TASKA HandGen2 Myoelectric Hand - 7 3/4 RH LP SandTASKA-C1CC21-U12026-01-07
09421906785159TASKA HandGen2 Myoelectric Hand - 7 3/4 RH QWD WhiteTASKA-C1FA21-U12026-01-07
09421906785166TASKA HandGen2 Myoelectric Hand - 7 3/4 RH QWD BlackTASKA-C1FB21-U12026-01-07
09421906785173TASKA HandGen2 Myoelectric Hand - 7 3/4 RH QWD SandTASKA-C1FC21-U12026-01-07
09421906785180TASKA HandGen2 Myoelectric Hand - 7 3/4 LH LP WhiteTASKA-C2CA21-U12026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04064411004343Myo PlusOtto Bock Healthcare Products GmbHIQZ2026-05-04
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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