# Ito Co., Ltd.

- Location (FDA's records): Rockville, MD
- FDA decisions: 8 (1999–2021): 8 510(k) clearances
- Product codes: ITH (2), IMI (2), BWK (1), NUW (1), IMJ (1), IPF (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 12 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Professional Distribution Systems, Inc.: 1 (https://510kreport.com/company/professional-distribution-systems)
- Sybaritic, Inc.: 1 (https://510kreport.com/company/sybaritic)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Inno-Health Technology, Inc.: 1 (https://510kreport.com/company/inno-health-technology)
- Pulse Life, Inc.: 1 (https://510kreport.com/company/pulse-life)
- Myotronics-Noromed, Inc.: 1 (https://510kreport.com/company/myotronics-noromed)
- Mettler Electronics Corp.: 1 (https://510kreport.com/company/mettler-electronics)
- Pti: 1 (https://510kreport.com/company/pti)

## Firms that cite its devices most
- Wuxi Jiajian Medical Instrument Co., Ltd.: 2 (https://510kreport.com/company/wuxi-jiajian-medical-instrument)
- Shian Jia Meei Enterprise Co., Ltd.: 1 (https://510kreport.com/company/shian-jia-meei-enterprise)
- Lhasa Oms, Inc.: 1 (https://510kreport.com/company/lhasa-oms)
- Mediseb, Ltd.: 1 (https://510kreport.com/company/mediseb)
- Newcare Products, LLC: 1 (https://510kreport.com/company/newcare-products)
- Pantheon Research: 1 (https://510kreport.com/company/pantheon-research)
- BTL Industries, Inc.: 1 (https://510kreport.com/company/btl-industries)
- Bonutti Research, Inc.: 1 (https://510kreport.com/company/bonutti-research)

## Its most-cited devices
- K081943: Model ES-130 (2008), cited by 4
- K990787: TRIO 300 (1999), cited by 3
- K992545: TM-300 Traction System (1999), cited by 2
- K112520: US-101L, US-103S (2011), cited by 1
- K203525: D function (2021), cited by 1
- K032793: US-100 Portable Ultrasound Therapy Unit (2003), cited by 1

## Recent decisions
- K203525: D function (May 5, 2021)
- K112520: US-101L, US-103S (Oct 26, 2011)
- K081943: Model ES-130 (Nov 24, 2008)
- K081247: TM-400 (Aug 25, 2008)
- K032793: US-100 Portable Ultrasound Therapy Unit (Oct 9, 2003)
- K022846: SW-180 Shortwave Therapy Unit (Jan 28, 2003)
- K990787: TRIO 300 (Oct 20, 1999)
- K992545: TM-300 Traction System (Sep 1, 1999)

Source page: https://510kreport.com/company/ito