FDA.reportPublic FDA data

Adam's Hand

Primary DI
08057971592012
Brand
Adam's Hand
Company
BIONIT LABS SRL
Model
AH02-LM3-W1+WL03-45
Device description
Adam's Hand - Left, Medium, White, Short Wrist + Short Wrist Lamination Kit 45
Published
2024-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
08057971592012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057971592012080579715920128057971592012

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 moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3908361946903support@bionitlabs.com

Regulatory Flags#

DUNS number
439080477
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057971594702Analog Amplifier with accessoriesAA03-602026-03-20
08057971594795Remote Wave ElectrodeAE03-602026-03-20
08057971594801Remote Wave ElectrodeAE03-602026-03-20
08057971594818Remote Wave ElectrodeAE03-602026-03-20
08057971594733Remote Wave ElectrodeAE03-602026-03-18
08057971594085Analog Amplifier with accessoriesAA03-602025-08-25
08057971594689Analog Amplifier with accessoriesAA03-602025-08-06
08057971594696Analog Amplifier with accessoriesAA03-602025-08-06
08057971594603Adam's HandAH02-RS3-B1-012025-12-17
08057971594566Adam's HandAH02-RS3-B1-012025-12-17
08057971593897Adam's SkinAS02-LS1-N12025-12-02
08057971593903Adam's SkinAS02-RS1-N12025-12-02
08057971592463Adam's HandAH02-RM3-B1-012025-11-21
08057971593989Adam's SkinAS02-RS1-N52025-11-21
08057971594870Adam's HandAH02-RM3-W1-01-L2025-11-05
08057971591442Adam's SkinAS02-LM1-N52025-10-28
08057971593781Adam's SkinAS02-LS1-A02025-10-28
08057971595358MyoLogicML02-012025-09-26
08057971595365MyoLogic ProML01-012025-09-26
08057971594009Adam's SkinAS02-RS1-N62025-09-17

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