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2K-QDA Motion/Gait Analysis System

by Human Performance Technologies, Inc.

510(k) K880631

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880631 Date21 Apr 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LXJ
Device Class
Class II
Regulation
21 CFR Part 890.5360
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 2K-QDA Motion/Gait Analysis System is an Interactive Rehabilitation Exercise Device used in Physical Medicine. It is designed for motion and gait analysis as part of rehabilitation assessment and treatment.

The device was cleared through the FDA 510(k) process under K880631 with a substantially equivalent decision on April 21, 1988. It is classified under product code LJX and regulation number 890.5360, and is manufactured by Human Performance Technologies, Inc. in East Setauket, NY.

Other devices from Human Performance Technologies, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 2K-QDA Motion/Gait Analysis System used for?

    The 2K-QDA Motion/Gait Analysis System is designed for motion and gait analysis as part of rehabilitation assessment and treatment in physical medicine. It functions as an interactive rehabilitation exercise device to evaluate patient movement patterns during therapy.

  • How was the 2K-QDA Motion/Gait Analysis System cleared for market?

    The device was cleared through the FDA 510(k) process under submission K880631, receiving a substantially equivalent decision on April 21, 1988. This clearance pathway confirms it is substantially equivalent to a legally marketed predicate device.

  • What regulatory classification applies to the 2K-QDA Motion/Gait Analysis System?

    The device is classified under product code LJX and regulation number 890.5360, placing it in the Interactive Rehabilitation Exercise Devices category within the physical medicine specialty. It is a Class II medical device as indicated by the FDA classification in the openfda field.