FDA 510(k) Applications for Medical Device Product Code "HIR"
(Perineometer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K142355 | Advanced Tactile Imaging, Inc. | Vaginal Tactile Imager | 05/28/2015 |
| K143580 | ANALYTICA LTD | PeriCoach | 03/18/2015 |
| K160758 | ANALYTICA LTD. | PeriCoach OTC | 07/11/2016 |
| K082436 | APIMEDS, INC | EXTT-101 | 05/29/2009 |
| K162689 | BIOINFINITY (M) SDN. BHD. | Vibrance Pelvic Trainer | 06/08/2017 |
| K141893 | BIOINFINITY (M)SDN.BHD. | VIBRANCE KEGEL DEVICE (VKD) | 12/18/2014 |
| K970145 | BIOSEARCH MEDICAL PRODUCTS, INC. | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) | 08/11/1997 |
| K945611 | CARDIO DESIGN PTY. LTD. | PERITRON | 02/08/1996 |
| K983052 | CARDIO DESIGN PTY. LTD. | PERITRON PERINEOMETER MODEL 9300V OR 9300A | 10/19/1998 |
| K002830 | COLONIAL MEDICAL SUPPLY | PELVIC MUSCLE THERAPY | 12/27/2000 |
| K994079 | DESCHUTES MEDICAL PRODUCTS, INC. | REFLEX TREATMENT SYSTEM | 03/01/2000 |
| K013612 | HOLLISTER, INC. | INCARE PELVIC FLOOR THERAPY SYSTEM | 03/19/2002 |
| K013653 | HOLLISTER, INC. | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE | 03/05/2002 |
| K960311 | HOLLISTER, INC. | PERINEOMETER | 04/18/1996 |
| K122800 | KAMABRY, INC., DBA INNER PEACE FOR WOMEN | INNER PEACE | 10/04/2013 |
| K023305 | KEGELMASTER 2000 LTD. | KEGELMASTER 2000 | 12/26/2002 |
| K993411 | MEGA ELECTRONICS LTD. | FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR | 01/10/2000 |
| K021115 | NAISSANCE HOLDINGS, LC | GYNEFLEX | 12/20/2002 |
| K002617 | NEEN DESIGN LTD. | PERIFORM PERINEOMETRIC PROBE, MODEL 8300 | 04/05/2001 |
| K121902 | ORELLE CORPORATION LTD | NATRATONE | 06/06/2013 |
| K011688 | PELVICFLEX, INC. | PELVICFLEXER EXERCISE DEVICE | 03/20/2002 |
| K210764 | Pelvital USA, Inc. | Flyte | 04/13/2021 |
| K212655 | Pelvital USA, Inc. | Flyte | 09/21/2021 |
| K200409 | Pelvital USA, Inc. | Pelvital System | 07/10/2020 |
| K193364 | Plus EV Holdings dba Intimate Rose | Intimate Rose Kegel Exercise System | 08/24/2020 |
| K002043 | PURDUE TECHNOLOGY PARK | PELVEX HOMETRAINER | 05/21/2001 |
| K171896 | Ralston Group | Feminine Personal Trainer (FPT) | 08/29/2017 |
| K140780 | REGULATORY INSIGHT, INC. | KEGEL SMART, KEGELSMART PEARL | 09/10/2014 |
| K133990 | REMENDIUM LABS, LLC | IEVA REHABILITATIVE POSITIONAL DEVICE | 10/09/2014 |
| K192270 | Renovia Inc. | LEva Pelvic Digital Health System | 11/22/2019 |
| K180637 | Renovia Inc. | leva Pelvic Floor Trainer | 04/04/2018 |
| K213913 | Renovia Inc. | leva Pelvic Health System | 06/30/2022 |
| K212495 | Renovia Inc. | Leva Pelvic Health System | 09/08/2021 |
| K002834 | SRS MEDICAL SYSTEMS, INC. | SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR | 11/29/2000 |
| K960508 | THE PROMETHEUS GROUP | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 | 01/16/1997 |
| K974036 | THE PROMETHEUS GROUP | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | 12/22/1997 |
| K981277 | VERIMED HOLDINGS, INC. | PERIFORM | 11/20/1998 |
| K221476 | X6 Innovations | Perifit | 02/10/2023 |
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