Identity
- Trade Name
- Tempo Insights FDA UDI
- Generic Name
- Home pharmaceutical management support software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- v1.1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B553TEMPOINSIGHTS110 FDA UDI
- 510(k) Number
- K190013 FDA UDI
- FDA Product Code
- LNX FDA UDI
- GMDN Term
- Home pharmaceutical management support software FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home pharmaceutical management support software
Tempo Insights by Welldoc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home pharmaceutical management support software.
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- myPKFiT for Healthcare Professionals — Takeda Pharmaceuticals U.S.A., Inc. · Class II
- iSage Rx — Amalgam Rx, Inc · Class II
- Insulia — Voluntis Sa. · Class II
- Health Optimizer — WELLDOC · Class II
- Conifer Connect Diabetes — WELLDOC · Class II
Cleared under the same submission
K190013 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Welldoc
Sources (1)
- FDA UDI 1fb8107d-838b-4150-a486-017ac784274a 34 fields · synced May 30, 2026