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FDA 510(k)

KOREBALANCE (KINESTHETIC ABILITY TRAINER)

K-Number: K070676 · 2007-04-18

ApplicantSportkat, LLC
Decision Date2007-04-18
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

KOREBALANCE (KINESTHETIC ABILITY TRAINER) is the device name listed in this FDA 510(k) record. The listed applicant is Sportkat, LLC. It received FDA 510(k) clearance on 2007-04-18 under 510(k) number K070676. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOREBALANCE (KINESTHETIC ABILITY TRAINER)?

KOREBALANCE (KINESTHETIC ABILITY TRAINER) is a medical device that received FDA 510(k) clearance on 2007-04-18. The listed applicant is Sportkat, LLC. The 510(k) number is K070676.

When did KOREBALANCE (KINESTHETIC ABILITY TRAINER) receive FDA 510(k) clearance?

KOREBALANCE (KINESTHETIC ABILITY TRAINER) received FDA 510(k) clearance on 2007-04-18, under 510(k) number K070676.

Who is the listed applicant for KOREBALANCE (KINESTHETIC ABILITY TRAINER)?

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

What is the FDA product code for KOREBALANCE (KINESTHETIC ABILITY TRAINER)?

The FDA product code for KOREBALANCE (KINESTHETIC ABILITY TRAINER) is LXV.

Related Clinical Trials

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: LXV)

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.

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