Cleared Traditional

K060043 - KHAN KINETIC TREATMENT DEVICE (KKT-M1)

K060043 · Optima Health Solutions International, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
76d
Days
-
Risk

K060043 is an FDA 510(k) clearance for the KHAN KINETIC TREATMENT DEVICE (KKT-M1). Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Optima Health Solutions International, Inc. (Vancouver, British Columbia, CA). The FDA issued a Cleared decision on March 23, 2006 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Optima Health Solutions International, Inc. devices

FDA 510(k) Submission Details - K060043

510(k) Number K060043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date March 23, 2006
Days to Decision 76 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 116d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

Product Code LXM Manipulator, Plunger-like Joint
Device Class -

Regulatory Peers - LXM Manipulator, Plunger-like Joint

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