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Perineometer

FDA product code HIR · Class 2 · Obstetrics/Gynecology

74

Registered devices

2

Adverse events

1

Recalls

65

510(k) clearances

Devices with this code

IVS-2 — PERSONAL MEDICAL CORP.Levina — ZMI ELECTRONICS LTD.Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.IVS-2 — PERSONAL MEDICAL CORP.Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Vaginal Sensor Unit TTL — Thought Technology Ltd.Peritron — Laborie Medical Technologies Canada ULC Myotrac 3 Unit — Thought Technology Ltd.Intimina KegelSmart — Leloi AB Hinge Health Pelvic Trainer by Perifit — X6 INNOVATIONS Rectal Sensor Unit TTL — Thought Technology Ltd.Pathway® — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE Tube for Vaginal Sensor, with 3-way Stopcock — Laborie Medical Technologies Canada ULC Probe, Manometry, Anal Sensor — Laborie Medical Technologies Canada ULC MEP — PERSONAL MEDICAL CORP.SenseRx -- Anal/Small Vaginal and Vaginal EMG — PERSONAL MEDICAL CORP.FemiScan — Bittium Biosignals Oy Perifit — X6 INNOVATIONS Levina — ZMI ELECTRONICS LTD.MEP — PERSONAL MEDICAL CORP.Vaginal Tactile Imager — Advanced Tactile Imaging, Inc.Peritron+ — Laborie Medical Technologies Canada ULC Tube for Anal Sensor, with 3-way Stopcock — Laborie Medical Technologies Canada ULC

Recent recalls

Date	Firm	Reason
2019-07-12	Ralston Group	The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not subm

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.