FDA Registration
Active
🇭🇰 Hong Kong
SPEEDY GREAT LIMITED
Reg #: 3012184208
·
FEI: 3012184208
·
Expires 2026
Products
12
Proprietary Names
141
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- SPEEDY GREAT LIMITED
- Registration Number
- 3012184208
- FEI Number
- 3012184208
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Flat A, G/F., Jupiter Terrace, 18 Jupiter Street
- City
- North Point
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K200636
Owner / Operator
- Firm Name
- Speedy Great Limited
- Operator Number
- 10049955
- Address
- Flat A, G/F., Jupiter Terrace, 18 Jupiter Street
- City
- North Point
- State
- HK-NOTA
- Postal Code
- 00000
- Country
- HK
- Correspondent
- Jane Wong
US Agent
- Business Name
- Lhasa OMS, Inc.
- Contact Name
- Matthew Pike
- Address
- 230 Libbey Pkwy
- City
- East Weymouth
- State
- MA
- ZIP
- 02189
- Country
- US
- [email protected]
- Phone
- 781 3401010
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electro-Acupuncture | BWK | Class U | Unknown | No | 2021-02-25 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2015-09-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2015-09-15 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-02-25 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-04-10 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2015-09-15 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2015-09-14 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-01-21 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2015-09-15 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2015-09-15 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2015-09-15 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2015-09-15 |
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
Tri-Bong Roller
STAR-22 MAGNETIC BALLS
Rolling Drum Gold Color
Finger Ring Gold x 2, Chrome x2
Dual Head Jade Roller 14.5 cm
ROLLER, SILVER COLOUR
Model CQ-27
Model CQ-36
TDP CQ-27 Heat Lamp
TDP CQ-36 Heat Lamp
AWQ-104LT
AWQ-104L
Tai Chi Master Acupuncture Needles
Tai Chi Gold Acupuncture Needles
Tai Chi Power 80 Acupuncture Needles
Tai Chi Acupuncture Needles
Seven Star Pipe
Tai Chi Fives Acupuncture Needles
Seven Star Hammer
Taylor Hammer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device