Keffort (MC-100, MC-100A)
FDA 510(k) K213133 · Oriental Inspiration Limited
510(k) numberK213133
Submission
- Device name
- Keffort (MC-100, MC-100A)
- Applicant
- Oriental Inspiration Limited
Hong Kong, CN - Received
- September 27, 2021
- Decision date
- April 13, 2022
- 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 |
|---|---|---|
| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | 04/19/2024SE |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)NUH · Traditional | 12/22/2021SE |
| K170269 | Hee HR MiniOHT · Traditional | 05/03/2017SE |
| K170260 | BC-001+ Acne PurifierOLP · Traditional | 04/25/2017SE |
| K032612 | Ir Forehead Thermometer, Model HV-T36FLL · Abbreviated | 02/19/2004SE |
Questions and answers
When was Keffort (MC-100, MC-100A) cleared by the FDA?
Keffort (MC-100, MC-100A) (K213133) received a 510(k) decision of Substantially Equivalent on April 13, 2022, 198 days after the submission was received.
What is the product code of K213133?
The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.