FDA Registration
Active
🇨🇦 Canada
Turtlebrace elbow adult, TBCoA
Reg #: 3017434835
·
FEI: 3017434835
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TURTLEBRACE
- Registration Number
- 3017434835
- FEI Number
- 3017434835
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6525 Rue Picard
- City
- Saint-Hyacinthe Quebec
- Country
- CA
Owner / Operator
- Firm Name
- Turtlebrace
- Operator Number
- 10083525
- Address
- 6525 Rue Picard
- City
- Saint-Hyacinthe
- State
- Quebec
- Postal Code
- J2S 1H3
- Country
- CA
- Correspondent
- Serge-Eric Blais
US Agent
- Business Name
- Kuro Medical LLC
- Contact Name
- Matt Kyle
- Address
- 7625 Golden Triangle Dr Ste G
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
- [email protected]
- Phone
- 612 6362035
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2021-11-29 |
Proprietary Names
Turtlebrace elbow adult, TBCoA
Turtlebrace heating bag (convection), TBSCC
Turtlebrace TLSO baby. TBBT
Turtlebrace wrist pediatric velcro, TBPPV
Turtlebrace TLSO adult, TBTA
Turtlebrace elbow pediatric, TBCoP
Turtlebrace wrist adult zip, TBPAZ
Turtlebrace ankle pediatric reinforced, TBCPR
Turtlebrace finger only universal, DUA
Turtlebrace ankle adult reinforced, TBCAR
Turtlebrace fingers add-ons universal, EDUA
Turtlebrace thumb add-on universal, EPUA
Turtlebrace ankle adult , TBCA
Turtlebrace elbow baby, TBBCo
Turtlebrace TLSO pediatric, TBTP
Turtlebrace wrist adult velcro, TBPAV
Turtlebrace wrist pediatric zip, TBPPZ
Turtlebrace ankle baby TBBC
Turtlebrace ankle pediatric, TBCP
Establishment Types
Manufacture Medical Device