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FDA 510(k)

Rapid2 Therapy System

K-Number: K162935 · 2017-03-10

Decision Date2017-03-10
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Rapid2 Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Magstim Company, Ltd.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K162935. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid2 Therapy System?

Rapid2 Therapy System is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Magstim Company, Ltd.. The 510(k) number is K162935.

When did Rapid2 Therapy System receive FDA 510(k) clearance?

Rapid2 Therapy System received FDA 510(k) clearance on 2017-03-10, under 510(k) number K162935.

Who is the listed applicant for Rapid2 Therapy System?

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

What is the FDA product code for Rapid2 Therapy System?

The FDA product code for Rapid2 Therapy System is OBP.

Other records listing Magstim Company, 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.

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Related Devices (Code: OBP)

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.

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.