Tempo Insights

GUDID B553TEMPOINSIGHTS100

Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.

WELLDOC, INC.

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• Primary Device ID: B553TEMPOINSIGHTS100
• NIH Device Record Key: a3fc9ac9-b4fb-4151-b741-20c395edcbb1
• Commercial Distribution Discontinuation: 2023-08-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tempo Insights
• Version Model Number: v1.0
• Company DUNS: 021217115
• Company Name: WELLDOC, 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553TEMPOINSIGHTS100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190013

FDA Product Code

• LNX: Medical Computers And Software

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-08
• Device Publish Date: 2022-12-12

On-Brand Devices [Tempo Insights]

• B553TEMPOINSIGHTS100: Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insig
• B553TEMPOINSIGHTS110: Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insig
• B553202175RX0: Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insig