Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021976927

FEI Number

3021976927

Entity Name

POINT ROBOTICS MEDTECH INC.

City/State/Country

Xindian Dist. New Taipei, TW

Establishment Address

7F., No. 219, Sec. 3, Beixin Rd., Xindian Dist. New Taipei 231, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Point Robotics MedTech Inc. (Owner Number: 10084311)

Owner / Operator Contact Address

5F, No.130, Sec. 2, Shengyi Rd., Hsinchu Science Park, Zhubei City, TW-HSQ 30261, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230087

PMA Number

N/A

All Registered Proprietary Names

"POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System POINT Kinguide Robotic-Assisted Surgical System POINT Kinguide Agile Hybrid Navigation System POINT Kinguide Agile Hybrid Navigation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-11-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-13

Official Correspondent

Wayne Kao

US Agent Details

Wayne Kao Business: Point Robotics Corp, USA Email: us.agent@pointroboticsinc.com Phone: (626) 6783360

Related Public Records

Same Entity

Point Robotics MedTech 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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021976927. Last updated year: 2026. Please use registration number 3021976927 when referencing this establishment in official correspondence.