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FDA 510(k)

TG-BODY MI&BODY S-TRAINER

K-Number: K122393 · 2013-12-10

ApplicantMiga Medical Co., Ltd.
Decision Date2013-12-10
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TG-BODY MI&BODY S-TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Miga Medical Co., Ltd.. It received FDA 510(k) clearance on 2013-12-10 under 510(k) number K122393. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TG-BODY MI&BODY S-TRAINER?

TG-BODY MI&BODY S-TRAINER is a medical device that received FDA 510(k) clearance on 2013-12-10. The listed applicant is Miga Medical Co., Ltd.. The 510(k) number is K122393.

When did TG-BODY MI&BODY S-TRAINER receive FDA 510(k) clearance?

TG-BODY MI&BODY S-TRAINER received FDA 510(k) clearance on 2013-12-10, under 510(k) number K122393.

Who is the listed applicant for TG-BODY MI&BODY S-TRAINER?

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

What is the FDA product code for TG-BODY MI&BODY S-TRAINER?

The FDA product code for TG-BODY MI&BODY S-TRAINER is NGX.

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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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