ABB 3BHE014135R0011 UAD149A00-0-11 PLC

ABB 3BHE014135R0011 UAD149A00-0-11 PLC

Technical data of product parameters

More time is needed to evaluate this complex issue to determine how these items and services
can be classified under Medicare Part B. In the meantime, classification, coverage, and
payment for these items will be made on an individual claim-by-claim basis by the MACs.
According to information submitted by Signifier Medical Technologies, LLC (SMT), the
eXciteOSA® control unit is a tongue neuromuscular stimulation device. The eXciteOSA®
starter kit consists of a control unit, disposable one-size fits all flexible silicone mouthpiece,
and USB-C charger. A smartphone application is used to control all functions of the device,3BHE014135R0011 UAD149A00-0-11
such as turning the device on and off. The eXciteOSA® functions by delivering
neuromuscular electrical stimulation therapy to the tongue during the wakeful state. A patient
operates the device by inserting the mouthpiece into the control unit, connecting the device to
a patient-controlled phone application, and placing the mouthpiece on the tongue. The
neuromuscular electrical stimulation effect is achieved with a low-pulsed frequency whose 3BHE014135R0011 UAD149A00-0-11
intensity can be modified by the user. The electrical stimulation is a series of pulsed bursts
with a sequence of alternating pulse and rests periods. The control unit can be repurposed for
multiple, successive patientsEstablished new HCPCS Level II code K1028 effective April 1, 2022, “Power source and
control electronics unit for oral device/appliance for neuromuscular electrical stimulation of
the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by 3BHE014135R0011 UAD149A00-0-11
phone application.”Signifier Medical Technologies, LLC (SMT), the manufacturer of the eXciteOSA® product
indicated that they neither opposed nor supported the preliminary benefit category
determination. They questioned the CMS statement that the “medically necessary function of
the device is a smartphone,” and indicated that the FDA has authorized SMT to market
eXciteOSA® with a remote control to address the smartphone concern. Due to this
complexity, they requested CMS to finalize a “no determination” BCD to allow more time to
evaluate this complex issue and for the MACs to make decisions on a claim-by-claim basis

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Introduction to main products

Focus on DCS, PLC, robot control system and large servo system.

Main products: various modules/cards, controllers, touch screens, servo drives.

Advantages: supply imported original products, professional discontinued parts, fast delivery, accurate delivery time,

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reminder

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