Question 1

What types of medical devices does 1073849 Ontario Limited manufacture?

Accepted Answer

1073849 Ontario Limited specializes in patient lifting and mobility solutions. Their products include general-purpose slings and harnesses for lifting patients, overhead track systems for transferring patients, and electrically-powered mobile lifts. They also offer stand-up assist devices, hammock slings, divided-leg slings, and gait rehabilitation harnesses. These devices are designed for use in clinical or home care settings to support patient transfers while prioritizing comfort and caregiver safety.

Question 2

Where is 1073849 Ontario Limited based?

Accepted Answer

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and device listings confirm its operational base within the country.

Question 3

Which regulatory registries list the devices made by 1073849 Ontario Limited?

Accepted Answer

The devices produced by 1073849 Ontario Limited are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which include patient lifting systems like slings, harnesses, and mobile lifts.

Question 4

How are the devices manufactured by 1073849 Ontario Limited classified under medical device regulations?

Accepted Answer

All devices listed under 1073849 Ontario Limited fall under Class I regulatory classification. This classification applies to low-risk devices like patient lifting slings, harnesses, and mobile lifts, where the risk to patients is minimal and generally involves non-invasive or short-duration use. Class I devices typically require less stringent premarket review but still must comply with FDA registration and UDI requirements.

Device	Model / Reference	Registries	Class	Status
Combi - Tollos	T015CPF	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-6-FB-F08-FL-FZ	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-600-LB-LI-L05-LN	FDA UDI	Class I	Active
Combi - Tollos	T015CXXF	FDA UDI	Class I	Active
Combi - Tollos	T015CPPMF	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXMF	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DELXXX	FDA UDI	Class I	Active
Walking Harness - Tollos	TSC015WSXX	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-600-LB-LI-L03-LR	FDA UDI	Class I	Active
Dual Turner - Tollos	T019DTX	FDA UDI	Class I	Active
Long Seat - Tollos	T015LPPF	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DELXXB	FDA UDI	Class I	Active
Long Seat - Tollos	T015LP-PSS	FDA UDI	Class I	Active
TAS Elite Harness	T016-BSO	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DELXB	FDA UDI	Class I	Active
Dual Turner - Tollos	T019DTM	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LA-LG-L03-LO	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LA-LG-L03-LR	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-600-LB-LI-L03-LN	FDA UDI	Class I	Active
Sally Tube - Tollos	ST-5829S	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019R-PSS	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-500-SC-SJ-SP-SV	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LB-LI-L03-LM	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-750-SB-SJ-SN-ST	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXF	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-600-LA-LG-L03-LM	FDA UDI	Class I	Active

1073849 Ontario Limited

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