Sense System with IBT Electrodes

FDA UDI

Class II (US FDA UDI)

by Infinite Biomedical Technologies LLC

Identity

Trade Name: Sense System with IBT Electrodes FDA UDI
Generic Name: Myoelectric hand prosthesis FDA UDI
Device Name: Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (without grips) FDA UDI
Model / Reference: 70101-2 FDA UDI
Description: Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (without grips) FDA UDI

Identifiers

Primary DI / UDI-DI: 00850004850046 FDA UDI
510(k) Number: K182112 FDA UDI
FDA Product Code: GXY FDA UDI
IQZ FDA UDI
GMDN Term: Myoelectric hand prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
890.3420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Analytical non-scalp cutaneous electrode Myoelectric hand prosthesis

Unlock the full potential of your hand with our advanced Sense System with IBT Electrodes, a cutting-edge powered artificial substitute for a missing or damaged hand. This innovative device features integral motor action and amplified muscle action potentials from voluntary contracting muscle in the residual limb, providing precise control over movements like gripping, pinching, and pointing. With its surface electrodes designed to conduct electrical signals to/from your skin, our Sense System with IBT Electrodes is an ideal solution for individuals who require a reliable and natural-looking prosthetic hand.

Similar devices

Also classified as Myoelectric hand prosthesis.

Remote Electrode — Otto Bock Healthcare Products GmbH · Class II
S-CHARGE — HUGH STEEPER LIMITED · Class I
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
BATTERY SYSTEM — HUGH STEEPER LIMITED · Class I
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
Remote Electrode — Otto Bock Healthcare Products GmbH · Class II

Cleared under the same submission

K182112 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Infinite Biomedical Technologies LLC

Sources (1)

FDA UDI 2d7eef00-ea44-4c7d-8f5b-142c82c62d73 35 fields · synced Jun 29, 2026