Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614756

FEI Number

3008161494

Entity Name

Phiten Co., Ltd.

City/State/Country

KYOTO, JP

Establishment Address

678 TEARAIMIZU-CHO,, KARASUMA DORI, NAKAGYO-KU, KYOTO 604-8152, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PHITEN (Owner Number: 9039743)

Owner / Operator Contact Address

1820 W CARSON ST, STE 201, Torrance, CA 90501, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

nano METAX Support/Brace - Elbow/Wrist/Knee/Ankle/Thigh/Calf/Foot/Finger/Hand/Neck/Shoulder/Back Phiten Arm Sleeve Phiten Calf Sleeve Waist Belt; Knee/Ankle Wraps; Compression Wraps METAX Elbow/Wrist/Knee/Ankle/Thigh/Shoulder Support; METAX Compression Arm/Calf Sleeve Aqua Titanium Compression Shorts/Pants nano METAX Support/Brace - Elbow/Wrist/Knee/Ankle/Thigh/Calf/Foot/Finger/Hand/Neck/Shoulder/Back METAX Waist Belt; Knee/Ankle Wraps; Compression Wraps nano METAX Support/Brace - Elbow/Wrist/Knee/Ankle/Thigh/Calf/Foot/Finger/Hand/Neck/Shoulder/Back nano METAX Tape - Discs, Roll Aqua-Titanium Wrap Metax Tape - Discs, Roll METAX Elbow/Wrist/Knee/Ankle/Thigh/Shoulder Brace Titanium Tape - Discs, Precut, Roll

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-03-25
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2007-09-11
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2001-07-06

Official Correspondent

HISAO FURUHATA

US Agent Details

HISAO FURUHATA Business: Optima Life Japan, Inc. dba PHITEN Email: furuhata@us-phiten.com Phone: (310) 7819160

Related Public Records

Same Entity

PHITEN

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 9614756. Last updated year: 2026. Please use registration number 9614756 when referencing this establishment in official correspondence.