Cleared Traditional

K032765 - STREET

K032765 is an FDA 510(k) clearance for STREET, manufactured by Permobil AB. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K032765 · Permobil AB · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
147d
Days
Class 2
Risk

K032765 is an FDA 510(k) clearance for the STREET. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Permobil AB (Timra, SE). The FDA issued a Cleared decision on January 30, 2004 after a review of 147 days - within the typical 510(k) review window.

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: 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 - K032765

510(k) Number K032765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date January 30, 2004
Days to Decision 147 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
31d slower than avg
Panel avg: 116d · This submission: 147d
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 593
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K032765.
SINON POWER WHEELCHAIR, SN-P401
K040320 · Sinon Corporation · Mar 2004
SINON POWER WHEELCHAIR, SN-W401
K040319 · Sinon Corporation · Feb 2004
C.T.M. POWER CHAIR, MODEL HS-1000
K040020 · C.T.M. Homecare Product, Inc. · Feb 2004
TANGO, MODELS, BP1
K031711 · American Bantex Corp. · Dec 2003
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K033206 · Emg Technology Co., Ltd. · Dec 2003
UB 140
K033827 · Rivertrail Mobility · Dec 2003
K032765 · STREET
Download PDF FDA Summary Permobil AB