Data / Medical devices / Hong Kong / Speedy Great Limited
Speedy Great Limited: FDA-registered device maker in North Point, Hong Kong, 10 510(k) clearances
Speedy Great Limited is registered with the FDA (registration 3012184208) in North Point, Hong Kong. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012184208
- Address
- Flat A, G/F., Jupiter Terrace 18 Jupiter Street, North Point, Hong Kong, 00000
- Owner or operator
- Speedy Great Limited (10049955)
- Roles
- Exporter to the US
- First device listed
- September 14, 2015
- Registered through
- 2026
- Brand names listed
- AWQ-104L, AWQ-104LT, Axus Es-5 Electro-Acupuncture Device, BIO-NORTH FLEX MAGNET 1"R, BIO-NORTH FLEX MAGNET 2X3.5", BIO-NORTH FLEX MAGNET 3"R, BIO-NORTH FLEX MAGNET 4X6", BIO-NORTH FLXE MAGNET 1.5"R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Exporter to the US | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Exporter to the US | accessdata.fda.gov |
| Insoles, Medical | KYS | 1 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Exporter to the US | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Exporter to the US | accessdata.fda.gov |
| Pack, Heat, Moist | IMA | 1 | Exporter to the US | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 3, 2021 | K200636 | AXUS ES-5 Electro-Acupuncture Device | BWK | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| June 19, 2006 | K060517 | POINTER EXCEL | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| June 19, 2006 | K060508 | POINTER PLUS | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| June 14, 2006 | K061080 | IR PRO 250 | ILY | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| April 6, 2006 | K050989 | AWQ-104 | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| September 6, 2005 | K050435 | E-STIM II | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| February 14, 2003 | K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Lhasa Medical, Inc. | accessdata.fda.gov |
| June 4, 2001 | K003538 | TDP CQ-27 HEAT LAMP | ILY | Substantially Equivalent | Lhasa Medical, Inc. | accessdata.fda.gov |
| September 30, 1996 | K963299 | HWA-TO ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Lhasa Medical, Inc. | accessdata.fda.gov |
| August 23, 1996 | K962916 | HUA-XIA ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Lhasa Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electro-Acupuncture
- All makers of Shield, Protective, Personnel
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Needle, Acupuncture, Single Use
- All makers of Insoles, Medical
- All makers of Massager, Therapeutic, Manual
Updated February 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.