Cleared Traditional

K921647 - REGAL MOTORIZIED 3 WHEELED VEHICLE

K921647 is an FDA 510(k) clearance for REGAL MOTORIZIED 3 WHEELED VEHICLE, manufactured by Bruno Independent Living Aids, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K921647 · Bruno Independent Living Aids, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
28d
Days
Class 2
Risk

K921647 is an FDA 510(k) clearance for the REGAL MOTORIZIED 3 WHEELED VEHICLE. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Bruno Independent Living Aids, Inc. (Oconomowoc, US). The FDA issued a Cleared decision on May 4, 1992 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 Bruno Independent Living Aids, Inc. devices

FDA 510(k) Submission Details - K921647

510(k) Number K921647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date May 04, 1992
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 191
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K921647.
FORTRESS 1704FS FOUR WHEEL SCOOTER
K922966 · Fortress Scientific , Ltd. · Aug 1992
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
K922967 · Fortress Scientific , Ltd. · Aug 1992
SUNRUNNER TE-777
K923193 · Pride Health Care, Inc. · Jul 1992
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
K921069 · Fortress Scientific , Ltd. · Apr 1992
SHOPRIDER - TE889
K920654 · Pride Health Care, Inc. · Mar 1992
THREE WHEEL SCOOTER
K915659 · Pride Health Care, Inc. · Jan 1992