Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007543825

FEI Number

3007543825

Entity Name

JANDTY HEALTH INC.

City/State/Country

Taichung, TW

Establishment Address

19F., No.307, Sec. 2, Taiwan Blvd., West District, Taichung 40360, TW

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

JANDTY HEALTH INC. (Owner Number: 10042370)

Owner / Operator Contact Address

19F., No.307, Sec. 2, Taiwan Blvd., West District, Taichung, TW-TXG 40360, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hyperice X 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-08-30
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-08-26
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-11-19
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2017-01-24
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-05-15

Official Correspondent

TODD LATTA

US Agent Details

Ian Kovacevich Business: Reflex Group Email: ian@reflexgrp.com Phone: (760) 8407761

Related Public Records

Same Entity

JANDTY HEALTH INC.

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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007543825. Last updated year: 2026. Please use registration number 3007543825 when referencing this establishment in official correspondence.