Identity
- Trade Name
- TempoSmart FDA UDI
- Generic Name
- Home pharmaceutical management support software FDA UDI
- Device Name
- 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
- 2.X FDA UDI
- Description
- 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
- B553202174RX0 FDA UDI
- 510(k) Number
- K230813 FDA UDI
- FDA Product Code
- NDC FDA UDI
- GMDN Term
- Home pharmaceutical management support software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 FDA UDI
- 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
Yes
FDA UDI
Over-the-Counter
No
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
TempoSmart by Welldoc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home pharmaceutical management support software.
- Insulia — Voluntis Sa. · Class II
- Insulia — Voluntis Sa. · Class II
- myPKFiT for Patients Mobile Application — Takeda Pharmaceuticals U.S.A., Inc. · Class II
- 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
K230813 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Welldoc
Sources (1)
- FDA UDI 7db99347-e8a3-44e4-a198-8d6b0a440caf 34 fields · synced Jun 8, 2026