Cleared Traditional

K992310 - TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.

K992310 is an FDA 510(k) clearance for TONICROSS TRICYCLES, manufactured by Rupiani Medical. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K992310 · Rupiani Medical · Physical Medicine device
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Nov 1999
Decision
116d
Days
Class 1
Risk

K992310 is an FDA 510(k) clearance for the TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Rupiani Medical (Vaulx En Velin, FR). The FDA issued a Cleared decision on November 2, 1999 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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.

View all Rupiani Medical devices

FDA 510(k) Submission Details - K992310

510(k) Number K992310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1999
Decision Date November 02, 1999
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 157
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K992310.
MANUAL WHEELCHAIR
K994185 · Major Mobility Products, Inc. · Jan 2000
E Z CHAIR
K993298 · Premier Designs · Nov 1999
SPECTRUM LIBRE WHEELCHAIR
K993640 · Freedom Designs, Inc. · Nov 1999
WHEELCHAIR (MANUAL, NOT ELECTRICAL)
K992884 · Foshan Machinery & Equipment Import & Export Co. · Nov 1999
MANUAL WHEELCHAIR
K992035 · Major Mobility Products, Inc. · Aug 1999
KENSTONE
K990139 · Kenda USA · Apr 1999