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FDA 510(k)

Unicare (K-UNICARE-USA)

K-Number: K230983 · 2023-10-20

ApplicantTenscare, Ltd.
Decision Date2023-10-20
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Unicare (K-UNICARE-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K230983. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unicare (K-UNICARE-USA)?

Unicare (K-UNICARE-USA) is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Tenscare, Ltd.. The 510(k) number is K230983.

When did Unicare (K-UNICARE-USA) receive FDA 510(k) clearance?

Unicare (K-UNICARE-USA) received FDA 510(k) clearance on 2023-10-20, under 510(k) number K230983.

Who is the listed applicant for Unicare (K-UNICARE-USA)?

The FDA 510(k) record lists Tenscare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unicare (K-UNICARE-USA)?

The FDA product code for Unicare (K-UNICARE-USA) is KPI.

Other records listing Tenscare, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232441Unipro (K-UNIPRO-US)K230926Ova+ (K-OVAP-USA)K231053Unicare (K-UNICARE-USA)K200694Perfect EMSK191312Perfect PFE

Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic 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.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagK251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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