Cleared Traditional

K983808 - ZIPPY

K983808 is an FDA 510(k) clearance for ZIPPY, manufactured by Pillar Technology, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K983808 · Pillar Technology, Inc. · Physical Medicine device
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Oct 1999
Decision
351d
Days
Class 2
Risk

K983808 is an FDA 510(k) clearance for the ZIPPY. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Pillar Technology, Inc. (Neodesha, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K983808

510(k) Number K983808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date October 14, 1999
Days to Decision 351 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 116d · This submission: 351d
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 530
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K983808.
AMIGO MODEL 680000 (AMIGO EXCITE F 350)
K992619 · Amigo Mobility Intl., Inc. · Oct 1999
FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
K992627 · Teftec Corp. · Oct 1999
FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
K992628 · Teftec Corp. · Oct 1999
PERMOBIL POWERED WHEELCHAIR 1280
K991658 · Permobil AB · Oct 1999
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)
K991090 · Dynamic Systems, Inc. · Sep 1999
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
K991119 · Invacare Corp. · Aug 1999
K983808 · ZIPPY
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