FDA Registration
Active
🇯🇵 Japan
ITO CO., LTD.
Reg #: 9613446
·
FEI: 1000533128
·
Expires 2026
Products
6
Proprietary Names
33
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ITO CO., LTD.
- Registration Number
- 9613446
- FEI Number
- 1000533128
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3-1-8 Sakae-cho
- City
- Kawaguchi Saitama
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K081943
Owner / Operator
- Firm Name
- ITO CO., LTD.
- Operator Number
- 9003170
- Address
- 3-1-8 Sakae-cho
- City
- Kawaguchi
- State
- Saitama
- Postal Code
- 332-0017
- Country
- JP
- Correspondent
- KENNETH L BLOCK
US Agent
- Business Name
- Ken Block Consulting
- Contact Name
- Kenneth Block
- Address
- 3400 N Central Expy Ste 100265
- City
- Richardson
- State
- TX
- ZIP
- 75080
- Country
- US
- [email protected]
- Phone
- 972 4809554
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electro-Acupuncture | BWK | Class U | Unknown | No | 2008-12-18 |
| Equipment, Traction, Powered | ITH | Class 2 | Physical Medicine | No | 2008-12-18 |
| Stimulator, Muscle, Powered, Dental | NUW | Class 2 | Physical Medicine | No | 2021-09-07 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-01-09 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2011-08-22 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2011-04-28 |
Proprietary Names
ES-130
TM-400
D function
ES-160
Accu-Patch Gold Plated Type with Tan Color Tape
Magrain Silver with Tan Color Tape, without pack, with Latex
Accu-Patch Stainless steel Type with Tan Color Tape with Latex
Accu-Patch Gold Plated Type with Clear Tape
Accu-Patch Stainless steel Type with Clear Tape
Magrain-5 Silver Type, without pack, with Latex
Magrain Conical Pellets with Tan Color Tape, without pack
Accu-Patch Titanium with Clear Tape
Magrain-5 Silver Type, without pack
Accu-Patch Stainless steel Type with Tan Color Tape
Magrain Silver with Clear Tape, without pack
Magrain Gold with Tan Color Tape, without pack
Accu-Patch Gold Plated Type with Tan Color Tape with Latex
Magrain Conical Pellets with Tan Color Tape, without pack, with Latex
Magrain Gold with Clear Tape, without pack
Accu-Patch Conical Pellets with Tan Color Tape, with Latex
Magrain Silver with Tan Color Tape, without pack
Magrain Gold with Tan Color Tape, without pack, with Latex
Accu-Patch Conical Pellets with Tan Color Tape
WAKAKUSA MOXA
CHANG'AN NEO DX MOXA
GOKUJO MOXA
GOLD MOUNTAIN MOXA
CHOSEI-KYU MOXA
NEEDLE MOXA ROLL
YUKI-NO-HANA MOXA
TSUBO-KYU NEO NEXT MOXA
YOMEI MOXA
FUKUJU MOXA
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device