Who is the manufacturer of KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)?

Breg, Inc. filed the 510(k) submission for KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) (K911795).

What is the FDA product code for KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)?

LXV. as a Class U device in the EN panel.

What is the regulatory pathway for KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)

K911795 · Breg, Inc. · LXV · Nov 19, 1991 · EN

Device Facts

Record ID	K911795
Device Name	KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
Applicant	Breg, Inc.
Product Code	LXV · EN
Decision Date	Nov 19, 1991
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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