Cleared Traditional

K072887 - G-TRAINER MEDICAL

K072887 is an FDA 510(k) clearance for G-TRAINER MEDICAL, manufactured by Alter-G, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K072887 · Alter-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
107d
Days
Class 1
Risk

K072887 is an FDA 510(k) clearance for the G-TRAINER MEDICAL. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Alter-G, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 25, 2008 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K072887

510(k) Number K072887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2007
Decision Date January 25, 2008
Days to Decision 107 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
9d faster than avg
Panel avg: 116d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BXB Exerciser, Powered

All 158
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K072887.
FLO-BOOT
K003272 · Discovery Group, LLC · Apr 2001
ANKLE CALF EXERCISER PHLEBOPUMP
K952975 · Prevent Products, Inc. · Sep 1996
E-Z FLEX
K953456 · Fluid Motion Biotechnologies, Inc. · Jan 1996
BTE CPM-10
K955105 · Baltimore Therapeutic Equipment Co. · Dec 1995
BTE CPM-20
K955106 · Baltimore Therapeutic Equipment Co. · Dec 1995
HAMEX TWO
K951028 · Northern Orthopaedic Products, Inc. · Dec 1995
K072887 · G-TRAINER MEDICAL
Download PDF FDA Summary Alter-G, Inc.