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
Hygiene Elite - Tollos	T015HPPF	FDA UDI	Class I	Active
Titan - Tollos	TX-1000-TC-TH-T01-TN	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DELX	FDA UDI	Class I	Active
Repositioning - Tollos	T017LX	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-500-SC-SI-SP-ST	FDA UDI	Class I	Active
Stratus II Ceiling Lift - Tollos	PC-4-PB-P99-PL-HB	FDA UDI	Class I	Active
Combi - Tollos	T015CPPF	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-6-FB-F08-FL-FV	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LB-LH-L03-LP	FDA UDI	Class I	Active
Titan - Tollos	TX-1000-TC-TH-T01-TM	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DELB	FDA UDI	Class I	Active
Steady Aid - Tollos	T016DX-PSS	FDA UDI	Class I	Active
Combi - Tollos	T015CXXX-PSS	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-750-SB-SI-SN-ST	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LA-LG-L03-LN	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DE	FDA UDI	Class I	Active
Steady Aid - Tollos	T016XXX	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LB-LH-L03-LN	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-6-FB-F21-FL-FV	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-750-SB-SI-SN-SV	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019R	FDA UDI	Class I	Active
Long Seat - Tollos	T015LMF	FDA UDI	Class I	Active
Steady Aid Elite - Tollos	T016DEB	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LB-LI-L04-LN	FDA UDI	Class I	Active
Walking Harness - Tollos	TSC015WSX	FDA UDI	Class I	Active
Hygiene Elite - Tollos	T015HF	FDA UDI	Class I	Active
Hygiene Elite - Tollos	T015HXXXF	FDA UDI	Class I	Active
Ultramove - Tollos	TQM2000-FR	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LA-LG-L03-LP	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-4-FB-F44-FM-FV	FDA UDI	Class I	Active
Sally Tube - Tollos	ST-5848S	FDA UDI	Class I	Active
Combi - Tollos	T015CMF	FDA UDI	Class I	Active
Combi - Tollos	T015CPMF	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-750-SB-SJ-SP-ST	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXXXXF	FDA UDI	Class I	Active
Cirrus Ceiling Lift - Tollos	FC-6-FB-F46-FL-FV	FDA UDI	Class I	Active
Repositioning - Tollos	T017LX-PSS	FDA UDI	Class I	Active
Multi-Purpose Bands - Tollos	T019RO-PSS	FDA UDI	Class I	Active
Steady Aid - Tollos	T016DP-PSS	FDA UDI	Class I	Active
Combi - Tollos	T015CXXXXF	FDA UDI	Class I	Active
Repositioning - Tollos	T017LXMG	FDA UDI	Class I	Active
Long Seat - Tollos	T015LXF	FDA UDI	Class I	Active
Long Seat - Tollos	T015LPPMF	FDA UDI	Class I	Active
Long Seat - Tollos	T015LPMF	FDA UDI	Class I	Active
Steady Aid - Tollos	TSA-500-SC-SJ-SP-ST	FDA UDI	Class I	Active
Combi - Tollos	T015CPP-PSS	FDA UDI	Class I	Active
UltraLift - Tollos	TUL-750-LB-LI-L03-LP	FDA UDI	Class I	Active
Steady Aid - Tollos	T016P	FDA UDI	Class I	Active
Repositioning - Tollos	T017LXB-PSS	FDA UDI	Class I	Active
Hygiene Elite - Tollos	T015HXF	FDA UDI	Class I	Active

1073849 Ontario Limited

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