Unicare (K-UNICARE-USA)
FDA 510(k) K230983 · Tenscare, Ltd.
510(k) numberK230983
Submission
- Device name
- Unicare (K-UNICARE-USA)
- Applicant
- Tenscare, Ltd.
Epsom, GB - Received
- April 6, 2023
- Decision date
- October 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | 08/30/2024SE |
| K230926 | Ova+ (K-OVAP-USA)NUH · Traditional | 12/15/2023SE |
| K231053 | Unicare (K-UNICARE-USA)NUH · Traditional | 08/18/2023SE |
| K200694 | Perfect EMSNUH · Traditional | 06/04/2021SE |
| K191312 | Perfect PFEKPI · Traditional | 11/01/2019SE |
| K142506 | TensCare KegelFitKPI · Traditional | 04/20/2015SE |
| K103698 | Tenscare Itouch Sure Model ItsKPI · Traditional | 06/21/2011SE |
| K082377 | Tenscare Itouch Model(S) Easy and PlusGZJ · Abbreviated | 02/09/2009SE |
| K023997 | Tenscare Ultima Nms/EmsIPF · Traditional | 03/03/2003SE |
| K020846 | Ultima TENS XL-A1GZJ · Traditional | 05/21/2002SE |
Questions and answers
When was Unicare (K-UNICARE-USA) cleared by the FDA?
Unicare (K-UNICARE-USA) (K230983) received a 510(k) decision of Substantially Equivalent on October 20, 2023, 197 days after the submission was received.
What is the product code of K230983?
The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.