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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 a medical device manufactured by Trinity Medical Solutions. It received FDA 510(k) clearance on 2025-08-29 under approval 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. It is manufactured by Trinity Medical Solutions. The 510(k) number is K251026.

When was Regenesis EMS Chair approved by the FDA?

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

What company makes Regenesis EMS Chair?

Regenesis EMS Chair is manufactured by Trinity Medical Solutions.

What is the FDA product code for Regenesis EMS Chair?

The FDA product code for Regenesis EMS Chair is KPI.

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Official Source

View on FDA Database →

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

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