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
Cirrus Ceiling Lift - Tollos	FC-7-FA-F08-FL-FV	FDA UDI	Class I	Active
Steady Aid - Tollos	T016	FDA UDI	Class I	Active
Combi - Tollos	T015CXXXX-PSS	FDA UDI	Class I	Active
Pinnacle Ceiling Lift - Tollos	FC-1-FB-F08-FL-FV	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-750-SB-SJ-SN-SV	FDA UDI	Class I	Active
Ultramove - Tollos	TQM2000-GR	FDA UDI	Class I	Active
Repositioning - Tollos	T017LXBE	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019RB-PSS	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-6-FB-F46-FL-FZ	FDA UDI	Class I	Active
Combi - Tollos	T015CXXXXMF	FDA UDI	Class I	Active
Combi - Tollos	T015C-PSS	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-500-SC-SI-SP-SV	FDA UDI	Class I	Active
Repositioning - Tollos	T017LXMBE	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F01-FL-FV	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F56-FL-FV	FDA UDI	Class I	Active
Sally Sheet - Tollos	SS-5875S	FDA UDI	Class I	Active
Long Seat - Tollos	T015LX-PSS	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F09-FL-FV	FDA UDI	Class I	Active
Walking Harness - Tollos	TSC015WSXXX	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F08-FL-FZ	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019R4	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-6-FA-F08-FL-FZ	FDA UDI	Class I	Active
Steady Aid - Tollos	T016XX	FDA UDI	Class I	Active
Titan - Tollos	TX-1000	FDA UDI	Class I	Unknown
Steady Aid - Tollos	TSA-750-SB-SI-SN-SU	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016PDE	FDA UDI	Class I	Active
Steady Aid - Tollos	T016X	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-500-SC-SI-SP-SU	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019RBO-PSS	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXXF	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXMF	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F15-FL-FZ	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXX-PSS	FDA UDI	Class I	Active
Repositioning - Tollos	T017LXMB	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F08-FL-FV	FDA UDI	Class I	Active
Combi - Tollos	T015CXF	FDA UDI	Class I	Active
Combi - Tollos	T015CXXXMF	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXXMF	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DELXXXB	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F11-FK-FV	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	00817956021269	FDA UDI	Class I	Active
Combi - Tollos	T015CP-PSS	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-600-LB-LH-L03-LN	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXXXMF	FDA UDI	Class I	Active
Repositioning - Tollos	T017LXM	FDA UDI	Class I	Active
Long Seat - Tollos	T015LF	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019RB4	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-7-FB-F46-FL-FZ	FDA UDI	Class I	Active
Stratus II Ceiling Lift - Tollos	PC-4-PB-P08-PL-HB	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016PDEB	FDA UDI	Class I	Active

1073849 Ontario Limited

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