HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.

FDA Device Registration & Listing · Shek Mun, Shatin, HK · Registration 3008959444

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008959444
FEI Number
3008959444
Entity Name
HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
City/State/Country
Shek Mun, Shatin, HK
Establishment Address
Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,, Shek Mun, Shatin --, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. (Owner Number: 9058334)
Owner / Operator Contact Address
Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,, Shek Mun, Shatin, HK-NOTA --, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

G3PRO Theragun Pro Theragun Elite Theragun Prime Plus Theragun PRO PLUS Theragun PRO PLUS Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System Theragun PRO PLUS Theragun PRO PLUS

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 2019-01-04
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-01-06
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2023-08-10
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2013-01-14
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2012-07-03
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2018-10-07
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2018-10-07
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2013-01-14
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2022-01-13
HRX Arthroscope Orthopedic Class 2 888.1100 2014-08-27
HRX Arthroscope Orthopedic Class 2 888.1100 2026-05-12
PHU Intra-Abdominal Pressure Monitoring Device Unknown Class U N/A 2020-01-06
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2020-01-06
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2020-01-06
KNM Device, Pressure Applying Physical Medicine Class 1 890.5765 2022-06-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2026-05-12
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2023-08-03
HRX Arthroscope Orthopedic Class 2 888.1100 2014-08-27
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2023-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

Albert Wai-Kit Chan Business: Law Offices Of Albert Wai-Kit Chan Email: Chank@Kitchanlaw.Com Phone: (718) 7991000

Related Public Records

Same Entity

HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3023281311 Automatic Enterprise (Thailand) Co., Ltd. Rayong, TH
3020978007 DONGGUAN BAO KANG DIAN ZI KE JI LIMITED Dongguan City Guangdong, CN

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
K242140 Jiale Health Technology Shenzhen Co., Ltd. Air Compression Leg Massager (K-705) 2025-03-17
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number Establishment Name Location
3016460723 ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD. Lishui Zhejiang, CN
3032903908 TECHDERM LLC Palm Beach Gardens, FL, US
3030407739 CL MEDIX INC Chantilly, VA, US
3009079475 Aerotel Ltd. Holon Central, IL
3025350087 LENYO WORLD LTD Budapest, HU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008959444. Last updated year: 2026. Please use registration number 3008959444 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.