Everyway Incontinence Stimulation System
FDA 510(k) K213116 · Everyway Medical Instruments Co.,Ltd
510(k) numberK213116
Submission
- Device name
- Everyway Incontinence Stimulation System
- Applicant
- Everyway Medical Instruments Co.,Ltd
Shenkeng District, New Taipei City, CN - Received
- September 27, 2021
- Decision date
- December 3, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KPI – Stimulator, Electrical, Non-Implantable, For Incontinence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5320
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KPI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260178 | Pelvic Muscle Trainer (KM510, KM516B)KPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 06/18/2026SE |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 05/14/2026SE |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional | Shenzhen Changkun Technology Co., Ltd. | 05/06/2026SE |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924…KPI · Traditional | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 04/28/2026SE |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional | Pontemedag | 04/17/2026SE |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional | Well-Life Healthcare , Ltd. | 02/12/2026SE |
| K251026 | Regenesis EMS ChairKPI · Traditional | Trinity Medical Solutions | 08/29/2025SE |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional | Verity Medical , Ltd. | 06/26/2025SE |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional | Zmi Electronics , Ltd. | 03/27/2025SE |
| K241516 | BTL-398KPI · Traditional | BTL Industries, Inc. | 02/10/2025SE |
More from BTL Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special | 11/21/2025SE |
| K222488 | Everyway Analog OTC TENSNUH · Traditional | 11/15/2022SE |
| K202849 | Everyway Analog OTC TENS, model N103A/N302NUH · Traditional | 12/22/2020SE |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUH · Traditional | 11/25/2020SE |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUH · Traditional | 11/13/2020SE |
| K201335 | Li-Battery powered OTC TENS/EMS Combination StimulatorNUH · Traditional | 10/24/2020SE |
| K192589 | Everyway OTC TENS/EMS CombinationNUH · Traditional | 12/19/2019SE |
| K182767 | V2 OTC Pain Relief TENSNUH · Special | 10/26/2018SE |
| K182753 | A6 OTC Pain Relief TENSNUH · Special | 10/26/2018SE |
| K181707 | Everyway Wireless TENS & EMS UnitNUH · Traditional | 09/26/2018SE |
Questions and answers
When was Everyway Incontinence Stimulation System cleared by the FDA?
Everyway Incontinence Stimulation System (K213116) received a 510(k) decision of Substantially Equivalent on December 3, 2021, 67 days after the submission was received.
What is the product code of K213116?
The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.