Unicare (K-UNICARE-USA)— 510(k) K230983
Substantially EquivalentTenscare, Ltd.
FDA 510(k) clearance K230983 for Unicare (K-UNICARE-USA), Substantially Equivalent on 2023-10-20. Applicant: Tenscare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Tenscare, 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
- Epsom, GB
Recent devices under product code KPI
view all- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252601 — Pelvic Muscle Trainer (4 models)
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- 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 Tenscare, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.