Everyway Incontinence Stimulation System— 510(k) K213116
Substantially EquivalentEveryway Medical Instruments Co.,Ltd
FDA 510(k) clearance K213116 for Everyway Incontinence Stimulation System, Substantially Equivalent on 2021-12-03. Applicant: Everyway Medical Instruments Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Everyway Medical Instruments Co.,Ltd
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenkeng District, New Taipei City, CN
Recent devices under product code KPI
view all- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252601 — Pelvic Muscle Trainer (4 models)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from Everyway Medical Instruments Co.,Ltd
view all- K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
- K222488 — Everyway Analog OTC TENS
- K202849 — Everyway Analog OTC TENS, model N103A/N302
- K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
- K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
Data sourced from openFDA. This site is unofficial and independent of the FDA.