510(k) K213133
- Device
- Keffort (MC-100, MC-100A)
- Applicant
- Oriental Inspiration Limited
- 510(k) number
- K213133
- Product code
- KPI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-13
- Date received
- 2021-09-27
- Regulation
- 876.5320
- Classification name
- Stimulator, Electrical, Non-implantable, For Incontinence
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Francis Ko
- Address
- Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre,# 57 Ting Kok Rd., Tai Po,New Territories Hong Kong CN
FDA Registration Numbers#
- 3042709404
- 3006850006
- 1063324
- 3013401749
- 9617486
- 3009736547
- 3007543044
- 3010511300
- 3019822804
- 3006636961
- 3027329006
- 3012316249
- 9680487
- 1718873
- 1224842
- 3017448360
- 3014405438
- 3017936974
- 3025376109
- 3035374386
- 3017264244
- 3012697062
- 3010405397
- 9616877
- 1417592
- 3011905669
- 3006897018
- 3009466220
- 8010720
- 3021815
- 3005170249
- 3003446042
- 3009617411
- 3004049909
- 3012477715
- 3013426279
- 3004839404
- 9613462
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-05-14 |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | Shenzhen Changkun Technology Co., Ltd. | 2026-05-06 |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 2026-04-28 |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | 2026-04-17 |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. | 2026-02-12 |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions | 2025-08-29 |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. | 2025-06-26 |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. | 2025-03-27 |
| K241516 | BTL-398 | BTL Industries, Inc. | 2025-02-10 |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | 2024-11-27 |
| K234061 | StarFormer | Fotona D.O.O. | 2024-07-01 |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | Shenzhen Konmed Technology Co., Ltd. | 2024-02-23 |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics , Ltd. | 2024-01-18 |
| K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023-10-20 |
| K230780 | MFG-05 | Zimmer Medizinsysteme GmbH | 2023-10-05 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases