Data / Medical devices / Japan / Ito Co., Ltd.
Ito Co., Ltd.: FDA-registered device maker in Kawaguchi Saitama, Japan, 4 510(k) clearances
Ito Co., Ltd. is registered with the FDA (registration 9613446) in Kawaguchi Saitama, Japan. It lists 6 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
- 9613446
- FEI number
- 1000533128
- Address
- 3-1-8 Sakae-cho, Kawaguchi Saitama, Japan, 332-0017
- Owner or operator
- ITO CO., LTD. (9003170)
- Roles
- Exporter to the US, Specification developer
- First device listed
- January 9, 2008
- Registered through
- 2026
- Brand names listed
- Accu-Patch Conical Pellets with Tan Color Tape, Accu-Patch Conical Pellets with Tan Color Tape, with Latex, Accu-Patch Gold Plated Type with Clear Tape, Accu-Patch Gold Plated Type with Tan Color Tape, Accu-Patch Gold Plated Type with Tan Color Tape with Latex, Accu-Patch Stainless steel Type with Clear Tape, Accu-Patch Stainless steel Type with Tan Color Tape, Accu-Patch Stainless steel Type with Tan Color Tape with Latex and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Exporter to the US | accessdata.fda.gov |
| Equipment, Traction, Powered | ITH | 2 | Specification developer | accessdata.fda.gov |
| Pack, Heat, Moist | IMA | 1 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, Dental | NUW | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Specification developer | 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 Device, Pressure Applying
- All makers of Equipment, Traction, Powered
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Pack, Heat, Moist
- 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.