Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012184208

FEI Number

3012184208

Entity Name

SPEEDY GREAT LIMITED

City/State/Country

North Point, HK

Establishment Address

Flat A, G/F., Jupiter Terrace, 18 Jupiter Street, North Point 00000, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Speedy Great Limited (Owner Number: 10049955)

Owner / Operator Contact Address

Flat A, G/F., Jupiter Terrace, 18 Jupiter Street, North Point, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Axus Es-5 Electro-Acupuncture Device E-Stim II E-Stim III FORCEPS CONTAINER METAL TRAY 11x3.5x1cm METAL TRAY 13.8X6.6X1.8cm SURGICAL TRAY Pointer Plus LT Pointer Plus GB-3 IR Heat Device Face Shield Cup E 1.9cm MAGNETIC NEEDLES, 3000 GAUSS Glass Cup Flat Top No. 3 Rect Shape 6.5 x 3.8cm Rubber Cup 3 cm WOODEN HAMMER & DOWL Glass Cup Flat Top No. 2 Rubber Cup 4.5 cm Glass Cup Flat Top No. 4 JADE MASSAGE BLADE HEART Matsuba-Pine Brush Shoni Shin Dual Probe 3-7/8" Cup D 2.6cm Pump N Cup 2cm Cup I Curved 3.5cm Sili Massage Facial Cup (pair) L Rolling Lion Warmer Chro Disposable Cup 2.8 cm, 2 pcs/pkt Rect. Shape 10 x 5.5cm (L) Pump N Cup 4cm SPRING AURICULAR PROBE Bachi-Bari Shoni Shin BIO-NORTH FLXE MAGNET 1.5"R Vaccaria Seed W/P - 50 BIO-NORTH FLEX MAGNET 2X3.5" Tiger Warmer (fine) Cup J Curved 2.7cm SPRING PROBE, DUAL (ION-SHIN) ELASTIC CUPPING JAR (TRANSPARENT) 4 PCS/SET Magnet Sheet Square 9x5mm Sili Massage Cup 5.5cm S (pair) Massager Rod, 9 cm MASSAGE ROD 12.5CM Cup C 3.6cm Spring Probe w Magnet Pump N Cup 3cm BIO-NORTH FLEX MAGNET 1"R Bio-North Flex Magnet 2"R Massager Blade Fish Shape Cup H Rectangle Rect. Shape w/ Finger Arch Probe w Germanium Diode Pestle Set 4pcs/Set Cup B 4.8cm FLEX MAGNET ROUND 4cm(1.5") Flex Magnet Round 5cm (2") Disposable Cup 4.5 cm, 2 pcs/pkt JADE MASSAGE BLADE RECTANGLE Disposable Cup 5 cm, 2 pcs/pkt Glass Cups Flat Top Set (1,2,3) Magnetic Ear Tac W/P-100 Longevity Brand Cupping Set W/16 Hoki Shonishin Choto-Sword Shaped Shonishin Sili Massage Cup 7cm L (pair) Cup A 5.7cm GLASS CUPPING SET 14PCS/SET XL Rolling Tiger Warmer Chro Yoneyama Copper Shoni Shin Vaccaria Seeds W/P-600 Rubber Cup 6 cm Dual Facial Probe Massager Rod, 11 cm BIO-NORTH FLEX MAGNET 3"R MASSAGE ROD 9CM Cup F 1.6cm Glass Cup Flat Top No. 1 Rect Shape 8x4.8cm (M) Pen Probe Cup G Triangle Heragata-Arrow Shape Shonishin CHOKI SHONI-SHIN Pump N Cup 5cm PROBE w ROLLER FLEX MAGNET ROUND 2.5cm (1" ) Disposable Cup 2.3 cm, 2 pcs/pkt BIO-NORTH FLEX MAGNET 4X6" S Rolling Lion Warmer Chrom IR Pro-250 Base w Wheel for IR Pro-250 Metal Plate for IR Pro-250 Hwa-To Acupuncture Needles Hwa-To Five Acupuncture Needles Hwa-To Basic Acupuncture Needles THERAvantage Pointer Excel Pointer Excel II-LT Pointer Excel II Magnetic Multi-Power Insole BIO-NORTH FOOT-STEPS Hua Xia Acupuncture Needles Hua Xia Basic Acupuncture Needles Nien Ying Moxa Rolls Moxa Roll 4 mm Super Pure G Moxa Sticks Smokeless Moxa Rolls Smokeless Moxa Rolls, Dia. 6mm Smokeless Small Size Moxa St Moxa Punk 100gm/pkt Small Size Moxa Stick Pure Moxa Punk 250gm/pkt Smokeless Pure Moxa Rolls Moxa Punk Golden 11001-1B Tai I Moxa Rolls MOXA PUNK 11001-3, 100GM /PKT Pure Moxa Sticks/500 Pcs Pure Moxa Rolls Huasun Smokeless Moxa Rolls Pure Moxa Stand 200 Pcs Vitality Smokeless Moxa Roll

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2021-02-25
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-09-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-09-15
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-09-14
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-02-25
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-10
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2015-09-15
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2015-09-14
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2015-09-14
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-01-21
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-09-14
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2015-09-15
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2015-09-14
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2015-09-15

Official Correspondent

Jane Wong

US Agent Details

Matthew Pike Business: Lhasa OMS, Inc. Email: mpikeoms@aol.com Phone: (781) 3401010

Related Public Records

Same Entity

Speedy Great Limited

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
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3007710601	WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD	Wuxi Jiangsu, CN
9614750	ITO CO., LTD. Tsukuba Factory	Inashiki-Gun Ibaraki, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012184208. Last updated year: 2026. Please use registration number 3012184208 when referencing this establishment in official correspondence.