FDA Registration
Active
🇲🇽 Mexico
TUTAMEN DE MEXICO, LLC
Reg #: 3013591868
·
FEI: 3013591868
·
Expires 2026
Products
16
Proprietary Names
14
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- TUTAMEN DE MEXICO, LLC
- Registration Number
- 3013591868
- FEI Number
- 3013591868
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle 9 sur ext 101 ciudad industrial, Baja Maq el Aguila
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K201431
Owner / Operator
- Firm Name
- Tutamen de Mexico, LLC
- Operator Number
- 10055035
- Address
- Aguila Coronada #19181, Baja Maq el Aguila
- City
- Tijuana
- State
- Baja California
- Postal Code
- 22215
- Country
- MX
US Agent
- Business Name
- Registrar corp
- Contact Name
- David Lennarz
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-04-10 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2020-07-22 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2019-03-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-24 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2024-02-15 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2021-01-25 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2019-06-07 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-03-09 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2022-10-25 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2017-07-07 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 2020-09-23 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2022-10-25 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2021-02-11 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2022-07-22 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2019-01-31 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-03-04 |
Proprietary Names
PBM Therapy
iWalk3 - Hands Free Crutch
TUT FACE SHIELD
Richmar Hydratherm
Smartbrace
Apex Liquid Medicine Dispenser
UltraSling Quadrant
Apex Ill Organizers
OG Back Brace
OGYILI TENS/NMES Stimulator
Procare Flat Collar
XTEND 174 Neck Brace
Ultra Zoom, Ultra CTS, Ultra High-5
iWalk 3 - Hands Free Crutch
Establishment Types
Manufacture Medical Device