Insight Discovery Thermal

GUDID 00890477000074

SRS Medical Systems, Inc.

Biofeedback system application software

• Primary Device ID: 00890477000074
• NIH Device Record Key: 0341035a-c12c-4c12-a9ba-33bda63f2c9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insight Discovery Thermal
• Version Model Number: 900-034
• 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	00890477000074 [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
• 00890477000074 - Insight Discovery Thermal: 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