FDA Registration
Active
🇹🇼 Taiwan
JANDTY HEALTH INC.
Reg #: 3007543825
·
FEI: 3007543825
·
Expires 2026
Products
6
Proprietary Names
16
Establishment Types
3
Classifications
6
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Registration Details
- Registration Name
- JANDTY HEALTH INC.
- Registration Number
- 3007543825
- FEI Number
- 3007543825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19F., No.307, Sec. 2, Taiwan Blvd., West District
- City
- Taichung
- Country
- TW
Owner / Operator
- Firm Name
- JANDTY HEALTH INC.
- Operator Number
- 10042370
- Address
- 19F., No.307, Sec. 2, Taiwan Blvd., West District
- City
- Taichung
- State
- TW-TXG
- Postal Code
- 40360
- Country
- TW
- Correspondent
- TODD LATTA
US Agent
- Business Name
- Reflex Group
- Contact Name
- Ian Kovacevich
- Address
- 5931 Sea Lion Place ., STE 105
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
- [email protected]
- Phone
- 760 8407761
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2021-08-30 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2021-08-26 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2012-11-19 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2017-01-24 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-05-15 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2017-05-15 |
Proprietary Names
Hyperice X
Nordt Knee Brace
Reaction Knee Brace
OA Reaction
OA Reaction Trifit
Trizone
Webtech
A22 Sleeve
OA Reaction Sleeve
OA Reaction Trifit Sleeve
Reaction Sleeve
Trizone Ankle Brace
SAEBOGLOVE
SAEBOFLEX
SAEBOREACH
SAEBOSTRETCH
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility