Cleared Traditional

K930676 - ACTION TIGER POWERED WHEELCHAIR

K930676 is an FDA 510(k) clearance for ACTION TIGER POWERED WHEELCHAIR, manufactured by Invacare Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 409-day FDA review.

K930676 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
409d
Days
Class 2
Risk

K930676 is an FDA 510(k) clearance for the ACTION TIGER POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 409 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Invacare Corp. devices

FDA 510(k) Submission Details - K930676

510(k) Number K930676 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 09, 1993
Decision Date March 25, 1994
Days to Decision 409 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 115d · This submission: 409d
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 K930676.
S500 SEATING SYSTEM
K933863 · Fortress Scientific , Ltd. · Mar 1994
720 POWER BASE
K933864 · Fortress Scientific , Ltd. · Mar 1994
ACTION STORM POWER WHEELCHAIR
K940051 · Invacare Corp. · Mar 1994
FORTRESS 760-N 4 WHEEL POWER WHEELCHAIR
K921070 · Fortress Scientific , Ltd. · May 1992
MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X
K914938 · Invacare Corp. · Jan 1992
SPECIALTY CONTROLS INTERFACE
K913645 · Everest & Jennings, Inc. · Dec 1991