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FDA 510(k)

Myolift QT

K-Number: K213078 · 2023-04-27

Decision Date2023-04-27
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Myolift QT is the device name listed in this FDA 510(k) record. The listed applicant is Johari Digital Healthcare Limited. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K213078. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Myolift QT?

Myolift QT is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Johari Digital Healthcare Limited. The 510(k) number is K213078.

When did Myolift QT receive FDA 510(k) clearance?

Myolift QT received FDA 510(k) clearance on 2023-04-27, under 510(k) number K213078.

Who is the listed applicant for Myolift QT?

The FDA 510(k) record lists Johari Digital Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myolift QT?

The FDA product code for Myolift QT is NFO.

Other records listing Johari Digital Healthcare Limited 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.

Related Devices (Code: NFO)

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.