Cleared Traditional

K884812 - KARMA-RS

K884812 is the FDA 510(k) clearance for KARMA-RS by Orthofab, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K884812 · Orthofab, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
40d
Days
Class 2
Risk

K884812 is an FDA 510(k) clearance for the KARMA-RS, KARMA-FS WHEELCHAIRS. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Orthofab, Inc. (Canada, Gim 1c2, CA). The FDA issued a Cleared decision on December 27, 1988 after a review of 40 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 Orthofab, Inc. devices

Submission Details

510(k) Number K884812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date December 27, 1988
Days to Decision 40 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 173
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K884812.
INVACARE POWER 9000 SERIES WHEELCHAIR
K900565 · Invacare Corp. · Feb 1990
ARROW MICRO COMPUTER CONTROL
K885212 · Invacare Corp. · Mar 1989
ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS
K885261 · Invacare Corp. · Mar 1989
MODEL #1551 SWITCH CONTROL INTERFACE UNIT
K880360 · Invacare Corp. · Sep 1988
MODEL #1552 ATTENDANT CONTROL OPTION
K880361 · Invacare Corp. · Sep 1988
MODEL #1553 RECLINER INTERFACE
K880362 · Invacare Corp. · Sep 1988