Cleared Traditional

K030714 - PEAK MOTUS

K030714 is an FDA 510(k) clearance for PEAK MOTUS, manufactured by Peak Performance Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K030714 · Peak Performance Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
71d
Days
Class 2
Risk

K030714 is an FDA 510(k) clearance for the PEAK MOTUS. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Peak Performance Technologies, Inc. (Centinnial, US). The FDA issued a Cleared decision on May 16, 2003 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - the FDA physical medicine device framework. 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 Peak Performance Technologies, Inc. devices

FDA 510(k) Submission Details - K030714

510(k) Number K030714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date May 16, 2003
Days to Decision 71 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXJ Device Classification - Class 2, Special Controls

Product Code LXJ Interactive Rehabilitation Exercise Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - LXJ Interactive Rehabilitation Exercise Devices

All 11
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K030714.
Jintronix
K143034 · Jintronix, Inc. · Apr 2015
SMART (SMART-D, SMART-DX)
K131660 · Bts S.P.A. · Apr 2014
JINTRONIX REHABILITATION SYSTEM (JRS)
K130847 · Jintronix, Inc. · Feb 2014
CODA MPX30 MOTION ANALYSIS SYSTEM
K982425 · Pinsco Inc. Dba B & L Engineering · Oct 1998
VICON
K811172 · Oxford Medilog, Inc. · Jun 1981