Cleared Traditional

K070489 - HEARTWAY POWER TILT SEATING SYSTEM POWE...

K070489 is an FDA 510(k) clearance for HEARTWAY POWER TILT SEATING SYSTEM POWE..., manufactured by Heartway Medical Products Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K070489 · Heartway Medical Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
22d
Days
Class 2
Risk

K070489 is an FDA 510(k) clearance for the HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Heartway Medical Products Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on March 14, 2007 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Heartway Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K070489

510(k) Number K070489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date March 14, 2007
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K070489.
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
K071005 · Heartway Medical Products Co., Ltd. · May 2007
HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
K071006 · Heartway Medical Products Co., Ltd. · May 2007
WU'S POWERED WHEELCHAIR, MAMBO 36
K070655 · Wu'S Tech Co., Ltd. · Apr 2007
WU'S POWERED WHEELCHAIR, MAMBO 2
K052559 · Wu'S Tech Co., Ltd. · Sep 2005
WU'S POWERED WHEELCHAIR, MAMBO 36X
K050010 · Wu'S Tech Co., Ltd. · Feb 2005
WU'S POWERED WHEELCHAIR, MAMBO F 120
K050011 · Wu'S Tech Co., Ltd. · Feb 2005