FDA Registration
Active
🇨🇦 Canada
THERMOR LTD.
Reg #: 3006537699
·
FEI: 3006537699
·
Expires 2026
Products
38
Proprietary Names
93
Establishment Types
1
Classifications
38
Registration Details
- Registration Name
- THERMOR LTD.
- Registration Number
- 3006537699
- FEI Number
- 3006537699
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 16975 Leslie Street
- City
- Newmarket Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K182629
Owner / Operator
- Firm Name
- Thermor Ltd.
- Operator Number
- 10037045
- Address
- 16975 Leslie Street
- City
- Newmarket
- State
- Ontario
- Postal Code
- L3Y 9A1
- Country
- CA
- Correspondent
- Iona Wenzel
US Agent
- Business Name
- GLOBAL TEST SUPPLY
- Contact Name
- KELLY GEYER-MEDINA
- Address
- 312 Raleigh St Ste 9
- City
- Wilmington
- State
- NC
- ZIP
- 28412
- Country
- US
- [email protected]
- Phone
- 910 4422164 ext. 5101
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2011-10-04 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-05-11 |
| Adult Portable Bed Rails For Medical Purposes | QTC | Class 1 | Physical Medicine | No | 2023-03-24 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-01-25 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2023-03-23 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2023-06-02 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-03-24 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2023-12-01 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2011-10-04 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2023-03-24 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-11-28 |
| Detectors And Removers, Lice, (Including Combs) | LJL | Class 1 | General Hospital | No | 2023-09-15 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-05-17 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2023-11-28 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2024-05-17 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2013-11-20 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2023-03-24 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2023-09-15 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2023-11-28 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2023-03-24 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-03-24 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2024-03-19 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2011-10-04 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2011-10-04 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2011-10-04 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2026-01-16 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2011-09-28 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2023-03-23 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2011-10-04 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-06-27 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-03-24 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2023-03-24 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2023-09-18 |
| Bath, Sitz, Nonpowered | KTC | Class 1 | Physical Medicine | No | 2011-10-04 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2023-09-15 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2012-09-17 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2023-09-15 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2023-09-18 |
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
BIOS Living Massage Roller: 55001, 57003, LG731, LG800, LG803,
BIOS Living Acupressure Mat, 59088
BIOS Living Cork Therapy Balls, LG802
BIOS Diagnostics Temp Scanner Non Contact Forehead 285DI
BIOS Diagnostics Non Contact Forehead Thermometer 275DI
BIOS Diagnostics Stethoscope: 506DI, 507DI, 508DI
BIOS Living Finger Cots, LK022
BIOS Living Bath Lift, 59023
Establishment Types
Export Device to the United States But Perform No Other Operation on Device