Home › Device types › HIR
Perineometer
FDA product code HIR · Class 2 · Obstetrics/Gynecology
76
Registered devices
2
Adverse events
1
Recalls
65
510(k) clearances
Devices with this code
U-Control 60Hz Unit TT — Thought Technology Ltd.InTone® — INCONTROL MEDICAL, LLCDelice — Blush NoveltiesInTone® by Viveve — INCONTROL MEDICAL, LLCLevina — ZMI ELECTRONICS LTD.InTone® NASP — INCONTROL MEDICAL, LLCLifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Flyte In-Home Pelvic Floor Treatment — PELVITAL USA, INC.Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THEWellness — Blush NoveltiesLifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.Flyte — PELVITAL USA, INC.Perifit — X6 INNOVATIONSIntimina KegelSmart - ML2(EN/IT/SV/FI) — Leloi ABIVS-2 — PERSONAL MEDICAL CORP.Peritron+ — Laborie Medical Technologies Canada ULCPathway® — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THEFemiScan — Bittium Biosignals OyPathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THEPathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THELifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
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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