LENS

GUDID G253LW30

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.

Ochs Labs LLC

Biofeedback system application software

• Primary Device ID: G253LW30
• NIH Device Record Key: 4956cff9-a7ad-484c-ab28-601c90962387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LENS
• Version Model Number: LW3
• Company DUNS: 081152913
• Company Name: Ochs Labs LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com
• Phone: 7078236225
• Email: info@ochslabs.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G253LW30 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by Ochs Labs LLC

• G253R30 - Regenesis 3: 2025-02-12 red/infrared light phototherapy unit
• G253LW30 - LENS: 2023-10-12NKPW 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.
• G253LW30 - LENS: 2023-10-12 NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeed