Home Uterine Activity Monitor
The Home Uterine Activity Monitor is a device used by pregnant patients in a home setting to detect and record uterine contractions, transmitting data to a healthcare provider for evaluation of preterm labor risk. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LQK, regulated under 21 CFR 884.2730, within the Obstetrics/Gynecology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LQK
- Device Class
- FDA class 2
- Regulation Number
- 884.2730
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221046 | Invu by Nuvo | May 06, 2022 | Substantially Equivalent | Nuvo- Group , Ltd. |
| K210025 | INVU by Nuvo | May 28, 2021 | Substantially Equivalent | Nuvo- Group , Ltd. |
| K191401 | PregSense | Mar 27, 2020 | Substantially Equivalent | Nuvo- Group , Ltd. |
| K143114 | Sense4Baby System Model B+ (MSA) | Mar 10, 2015 | Substantially Equivalent | Airstrip Technologies, Inc. |
| K020390 | MODIFICATION TO FETAL ASSIST | Apr 19, 2002 | Substantially Equivalent | Huntleigh Diagnostics , Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.