Data / Medical devices / Japan / ITO CO., LTD. Tsukuba Factory
ITO CO., LTD. Tsukuba Factory: FDA-registered device maker in Inashiki-Gun Ibaraki, Japan, 4 510(k) clearances
ITO CO., LTD. Tsukuba Factory is registered with the FDA (registration 9614750) in Inashiki-Gun Ibaraki, Japan. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 5, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614750
- FEI number
- 3004546558
- Address
- 3-39-14 Uzurano Ami-Machi, Inashiki-Gun Ibaraki, Japan, 300-0341
- Owner or operator
- ITO CO., LTD. (9003170)
- Roles
- Manufacturer
- First device listed
- January 9, 2008
- Registered through
- 2026
- Brand names listed
- D function, ES-130, ES-160, TM-400
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Equipment, Traction, Powered | ITH | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, Dental | NUW | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 5, 2021 | K203525 | D function | NUW | Substantially Equivalent | Ito Co., Ltd. | accessdata.fda.gov |
| November 24, 2008 | K081943 | MODEL ES-130 | BWK | Substantially Equivalent | Ito Co., Ltd. | accessdata.fda.gov |
| August 25, 2008 | K081247 | TM-400 | ITH | Substantially Equivalent | Ito Co., Ltd. | accessdata.fda.gov |
| February 24, 2006 | K051020 | ES-160 | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electro-Acupuncture
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Equipment, Traction, Powered
- All makers of Stimulator, Muscle, Powered, Dental
Updated May 5, 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.