Chrysalis Intelligence · Product Codes · LQK

LQK · Home Uterine Activity Monitor

Obstetrics/Gynecology · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 884.2730
Total clearances
3
2020-03-27 → 2022-05-06
Last 12 months
0
Unique sponsors
1
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.2730
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Nuvo- Group , Ltd. 3 0 2022-05-06
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
99500 CPT Medium Home visit for monitoring; obstetric patient assessment
A9279 HCPCS Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified ✓ CMS-verified description Medium Home uterine monitor rental/supply; direct device billing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2022-05-06 K221046 Nuvo- Group , Ltd. Invu by Nuvo
2021-05-28 K210025 Nuvo- Group , Ltd. INVU by Nuvo
2020-03-27 K191401 Nuvo- Group , Ltd. PregSense