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FDA 510(k)

Talent-Pro Electromagnetic Stimulator

K-Number: K202031 · 2021-05-06

ApplicantRemed Co., Ltd.
Decision Date2021-05-06
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Talent-Pro Electromagnetic Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Remed Co., Ltd.. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K202031. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Talent-Pro Electromagnetic Stimulator?

Talent-Pro Electromagnetic Stimulator is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Remed Co., Ltd.. The 510(k) number is K202031.

When did Talent-Pro Electromagnetic Stimulator receive FDA 510(k) clearance?

Talent-Pro Electromagnetic Stimulator received FDA 510(k) clearance on 2021-05-06, under 510(k) number K202031.

Who is the listed applicant for Talent-Pro Electromagnetic Stimulator?

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

What is the FDA product code for Talent-Pro Electromagnetic Stimulator?

The FDA product code for Talent-Pro Electromagnetic Stimulator is IPF.

Other records listing Remed Co., 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.

K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemK202537ALTMS Magnetic Stimulation Therapy System

Related Devices (Code: IPF)

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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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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