Chrysalis Intelligence · Product Codes · HIR

HIR · Perineometer

Obstetrics/Gynecology · 12 clearances · 6 unique sponsors

Device class
Class II
Regulation 884.1425
Total clearances
12
2020-07-10 → 2026-04-27
Last 12 months
1
Unique sponsors
6
Medical specialty
Obstetrics/Gynecology
Review panel
GU
Regulation number
884.1425
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
Pelvital USA, Inc. 5 0 2024-08-01
X6 Innovations 2 0 2023-12-20
Renovia, Inc. 2 0 2022-06-30
Plus EV Holdings Dba Intimate Rose 1 0 2020-08-24
Advanced Tactile Imaging, Inc. 1 0 2024-02-22
Hunan Accurate Bio-Medical Technology Co., Ltd. 1 1 2026-04-27
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
97750 CPT Medium Physical medicine pelvic floor muscle assessment; perineometer measures pelvic floor strength
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-27 K252748 Hunan Accurate Bio-Medical Technology Co., Ltd. Pelvic Floor Exerciser (PF01)
2024-08-01 K240805 Pelvital USA, Inc. Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
2024-02-22 K231875 Advanced Tactile Imaging, Inc. Vaginal Tactile Ultrasound Imager
2023-12-29 K233362 Pelvital USA, Inc. Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
2023-12-20 K231780 X6 Innovations Perifit Care+
2023-02-10 K221476 X6 Innovations Perifit
2022-06-30 K213913 Renovia, Inc. leva Pelvic Health System
2021-09-21 K212655 Pelvital USA, Inc. Flyte
2021-09-08 K212495 Renovia, Inc. Leva Pelvic Health System
2021-04-13 K210764 Pelvital USA, Inc. Flyte
2020-08-24 K193364 Plus EV Holdings Dba Intimate Rose Intimate Rose Kegel Exercise System
2020-07-10 K200409 Pelvital USA, Inc. Pelvital System