Insight Discovery PWP

GUDID 00890477000081

SRS Medical Systems, Inc.

Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software Biofeedback system application software

• Primary Device ID: 00890477000081
• NIH Device Record Key: 6085db14-6031-4255-a243-906b5c639230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insight Discovery PWP
• Version Model Number: 900-036
• Company DUNS: 796263598
• Company Name: SRS Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00890477000081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063447

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: 2021-08-30
• Device Publish Date: 2021-08-20

Devices Manufactured by SRS Medical Systems, Inc.

• 00890477000364 - EasyFlo Console: 2023-05-04
• 00890477000166 - Discovery Base Unit: 2022-11-28
• 00890477000074 - Insight Discovery Thermal: 2021-08-30
• 00890477000081 - Insight Discovery PWP: 2021-08-30
• 00890477000081 - Insight Discovery PWP: 2021-08-30
• 00890477000104 - Insight Discovery Dual Inclinometer: 2021-08-30
• 00890477000159 - Insight Discovery Algometer: 2021-08-30
• 00890477000173 - Insight Discovery PWP (w/cable): 2021-08-30
• 00890477000180 - EMG Sensor: 2021-08-30