Lens

NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart…

Registry build 21.09.26

NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. HJLM Biofeedback system application software An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (5), Hebei (1).

Chinese manufacturers registered for FDA product code HCC
Manufacturer City Province Registered as Device types
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Shenzhen Konmed Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Shenzhen XFT Medical Limited Shenzhen Guangdong Manufacturer 8
ISA Mould Engineering Limted Dongguan Guangdong Contract manufacturer 4
Qinhuangdao Huisianpu Medical Systems Inc. Qinhuangdao Hebei Manufacturer 4
Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for Lens
Listed by Ochs Labs, LLC, United States
FDA product code HCC
Device type Device, Biofeedback
Device class Class 2
Regulation 21 CFR 882.5050
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-10-04

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Lens
Catalogue number Size Status
LW3 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ultium Noraxon U.S.A., Inc. 23
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Ondamed Ondamed Inc. 15
MyoPro Myomo, Inc. 12
TeleMyo Noraxon U.S.A., Inc. 12
Recording Cap G1 Deymed Diagnostic S.R.O. 8
HAL for Medical Use Cyberdyne Inc. 8
Disc Electrode 9mm Sn (Tin) Deymed Diagnostic S.R.O. 8
Axon Exsurgo Limited 8
Innara Health Innara Health, Inc. 7
Kangaroo Cardinal Health 200, LLC 7
SX230-1000 EMG Sensor Biometrics Ltd. 6

Showing 12 of 241. All products under Device, Biofeedback

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer