Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005492707

FEI Number

3005492707

Entity Name

Shandong Kangtai Intelligent Technology Co., Ltd.

City/State/Country

Zhaoyuan Shandong, CN

Establishment Address

389 Jincheng Rd, 98 East Chushan Rd, Zhaoyuan Shandong 265400, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shandong Kangtai Intelligent Technology Co., Ltd. (Owner Number: 10035275)

Owner / Operator Contact Address

389 Jincheng Rd., 98 East Chushan Rd., Zhaoyuan, CN-SD 265400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Osaki ZIVA DREAMCATCHER ZA-171 Titan Pro 4D Astro ZA-182 Osaki Grand duo Titan Ultra 2 Osaki Apex duo 5D+4D Amamedic Pro 4D Haven Titan 3D Drift Positive Posture Solara PP1915 OHCO M.8 NEO TS-8500, TS-9900, TS-10000 Osaki Grand duo 5D+4D Infinity Riage 4D DualFlex(RK8101D) Positive Posture Brio Sport Positive Posture DualTech PP2005 Titan Ignite Duo NR100 RK2005S DUOMEC AI Osaki Karios SNE 202 Osaki Karios Duo 5D+4D OHCO M.8LE NEO DuoMec AI Osaki OS-Duke XL Titan Telos Positive Posture Brio+ Jacuzzi JPro704XR Titan Ignite Sync Titan Former 3D LP-021, LP-160, LP-161, LP-162, LP-083 Osaki OP-Karios 4D LT DT 101 SNE 226 Jacuzzi JPro503XR Medical Marvel V.3 Dual Roller FBMC-746-4D CT102 Hatsumei M900 AI(RK7601G) ANS-25, ANS-26, ANS-27, ANS-28, ANS-29 OSAKI RESERVE DUO ExecWave ZA-201 Osaki Aspen 5D Jacuzzi JPro506XR Titan Malibu Sync Osaki OS-Highpointe 4D Titan Malibu Duo Osaki Atlas XL Infinity Sensation 4D DualFlex(RK8102B)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2011-02-17

Official Correspondent

Sally Sun

US Agent Details

Finance Department Email: finance@fflbrands.com Phone: (303) 5725000

Related Public Records

Same Entity

Shandong Kangtai Intelligent Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005492707. Last updated year: 2026. Please use registration number 3005492707 when referencing this establishment in official correspondence.