Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006537699

FEI Number

3006537699

Entity Name

THERMOR LTD.

City/State/Country

Newmarket Ontario, CA

Establishment Address

16975 Leslie Street, Newmarket Ontario L3Y 9A1, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Thermor Ltd. (Owner Number: 10037045)

Owner / Operator Contact Address

16975 Leslie Street, Newmarket, CA-ON L3Y 9A1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BIOS Living Ice Bag 57009 BIOS Diagnostics High Precision Thermometer with Bluetooth 239DI BIOS Diagnostics Instant Response Fever Thermometer 237DI BIOS Living Bed Rail LF838 BIOS Diagnostics Blood Pressure Monitor/Automatic AFIB, BD410 BIOS Diagnostics Easy Read Blood Pressure Monitor: BD201, BD290 BIOS Diagnostics Precision Blood Pressure Monitor BD240 BIOS Diagnostics Insight Blood Pressure Monitor BD252 BIOS Diagnostics Simplicity Blood Pressure Monitor BD313 BIOS Diagnostics Clarity Blood Pressure Monitor BD323 BIOS Living Crutches 56034, 56035, 56036 BIOS Living Diabetic Socks: 70026 - 70037 BIOS Living Diabetic Sock Bundles: 80025 - 80029, and 80031, 80032, 80037 BIOS Living Compression Hose Bundles: 80019, 80021 - 80024, and 80036 BIOS Living Compression Socks: 70001 - 70018 BIOS Living Compression Sock Bundles: 80002, 80004, 80005, 80007 - 80018, and 80033 - 80035 BIOS Living Compression Hose: 70019, and 70021 - 70025 BIOS Living Back Support LK045, LK046 BIOS Diagnostics 5 Second Digital Thermometer 227DI BIOS Diagnostics Flexible Fast Read Thermometer 238DI BIOS Diagnostics Character Flex Tip Thermometer 32704 BIOS Living Reusable Underpad, 57005 BIOS Living Onyx Rollator RL021 BIOS Living Aluminum Folding Walker BD770, 56120 BIOS Living Rollator BD749 BIOS Living Walker with Wheels 56023, 56004 BIOS Living Elbow Brace LK042 BIOS Living Hot & Cold Gel Compress: LH270, LH271, LH272 BIOS Living Instant Hot Pack: LH275 BIOS Living Gel Bead Hot/Cold: LH190, LH191, LH192, LH193, LH194, LH526 BIOS Living Cooling Gel Pad: LH300 BIOS Living Gel Bead Hot/Cold Bundles: PM001, PM002 BIOS Living Lice Comb Kit, LK130 BIOS Living Universal Arm Sling, FA102 BIOS Living Cast Protector: LF094, LF095, LF096, LF097,LF098, LF099 BIOS Living Cervical Collar, FA101 BIOS Living Therma-Ball Natural Heat Stress Ball 57044 BIOS Diagnostics Fingertip Pulse Oximeter 112PO BIOS Diagnostics Wrist Blood Pressure Monitor, W250 BIOS Living Rehab Glider, 57118 BIOS Diagnostics Cooling Patches, CP305 BIOS Living Wrist Splint LK047 BIOS Living Finger Splint, LG413, LG431, LK017, LK018 BIOS Living Wrist Support LK044 BIOS Living Heating Pad w/moist heat 57064, 57065 BIOS Living Utensils: ED101 BIOS Living Bath Seat 59002 BIOS Living Transfer Bench LF740, LF741 BIOS Living Raised Toilet Seat 59013, 59056, 59056L, 59057, 59057L, 59058, 59058L, LF775, LF776 BIOS Living Adjustable Bath Seat with Backrest 59001 BIOS Living Adjustable Shower Stool 59005 BIOS Living Toilet Safety, LF758, LF759 BIOS Living Deluxe Commode 59024 BIOS Living Disposable Underpad: 58020, 58021, 58022, 58023 BIOS Living Grab Bar 56089, 56090, 56091, 56087 BIOS Living Bathtub Safety Rail - Clamp-on BD715 BIOS Living Standing Aid, 56300 BIOS Living Turning Cushion, SP001 BIOS Living Bath Board, LF773 BIOS Living Transfer Bench, LF766, LF767 BIOS Living Car Handle Mobility Aid, 57221 BIOS Living Suction Grab Bar LF790, LF791, LF792 BIOS Diagnostics Nasal Aspirator NS150 BIOS Living 5/8 cane tip 56029 BIOS Living 5 star ice pick 56032 BIOS Living Crutch hand grip 56038 BIOS Living Crutch pads 56039 BIOS Living Crutch Tip 56037 BIOS Living 3/4 cane tip 56028 BIOS Living 7/8 Cane Tip 56027 BIOS Living walker skiis 56033 BIOS Living 1" cane tip 56026 BIOS Living Quad Cane Tip, BD829, BD830 BIOS Living Derby Canes: 56011, 56022, BD784, BD785 BIOS Living J-handle Canes: 56016, BD786, BD787 BIOS Living Folding Canes: BD768, BD783 BIOS Living Quad Canes: BD734, BD735 BIOS Living Orthopedic Canes: 56017, 56018 BIOS Living Offset Canes: 56005, 56015, BD775 - BD782 BIOS Living Transportation Chair 56053 BIOS Living Bandages: FA103, FA104, FA105, FA106, FA107, FA120 BIOS Living Knee Support, LK043 BIOS Living Ankle Support LK048 BIOS Professional Disposable Face Masks, FS600 BIOS Living Sitz Bath 57006

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2011-10-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-05-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-03-02
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2023-03-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-01-25
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-12
IPR	Crutch	Physical Medicine	Class 1	890.3150	2023-03-23
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2023-06-02
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-03-24
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-09-04
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2023-12-01
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2011-10-04
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-03-24
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-11-28
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2023-09-15
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-05-17
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2023-11-28
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2024-05-17
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2013-11-20
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2023-03-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-01-16
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2023-09-15
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2023-11-28
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-03-24
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-03-24
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2024-03-19
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2011-10-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2011-10-04
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2011-10-04
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2026-01-16
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2011-09-28
IPS	Cane	Physical Medicine	Class 1	890.3075	2023-03-23
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2011-10-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-06-27
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-03-24
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-03-24
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2023-09-18
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2011-10-04

Official Correspondent

Iona Wenzel

US Agent Details

KELLY GEYER-MEDINA Business: GLOBAL TEST SUPPLY Email: kgeyer-medina@globaltestsupply.com Phone: (910) 4422164

Related Public Records

Same Entity

Thermor Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.

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3044150131	Shanghai Jolly Industrial Co., Ltd.	Shanghai, CN
1000175697	HARITEX CORPORATION	TAIPEI CITY, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006537699. Last updated year: 2026. Please use registration number 3006537699 when referencing this establishment in official correspondence.