Nonimplanted Electrical Continence Device
FDA 510(k) K891007 · Tridak Division of Indicon, Inc.
510(k) numberK891007
Submission
- Device name
- Nonimplanted Electrical Continence Device
- Applicant
- Tridak Division of Indicon, Inc.
Williston, VT, US - Received
- February 27, 1989
- Decision date
- June 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| 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 |
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| K860744 | Opthalmic Surgical InstrumentsHMX · Traditional | 03/31/1986SE |
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| K851934 | Cytological Cervical Spatula the Multi-SpatulaHHT · Traditional | 07/05/1985SE |
| K842609 | R.L. Medical Twin Light SourceFCW · Traditional | 08/09/1984SE |
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Questions and answers
When was Nonimplanted Electrical Continence Device cleared by the FDA?
Nonimplanted Electrical Continence Device (K891007) received a 510(k) decision of Substantially Equivalent on June 7, 1990, 465 days after the submission was received.
What is the product code of K891007?
The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.