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FDA 510(k)

Regenesis EMS Chair

K-Number: K251026 · 2025-08-29

ApplicantTrinity Medical Solutions
Decision Date2025-08-29
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Regenesis EMS Chair is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Medical Solutions. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251026. 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 Regenesis EMS Chair?

Regenesis EMS Chair is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Trinity Medical Solutions. The 510(k) number is K251026.

When did Regenesis EMS Chair receive FDA 510(k) clearance?

Regenesis EMS Chair received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251026.

Who is the listed applicant for Regenesis EMS Chair?

The FDA 510(k) record lists Trinity Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Regenesis EMS Chair?

The FDA product code for Regenesis EMS Chair is KPI.

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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