# Koalaty Products, Inc.

- Location (FDA's records): Tampa, FL
- FDA decisions: 3 (2007–2010): 3 510(k) clearances
- Product codes: IPF (2), GZJ (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Everyway Medical Instruments Co.,Ltd: 3 (https://510kreport.com/company/everyway-medical-instruments)
- Shenzhen Dongdixin Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-dongdixin-technology)

## Firms that cite its devices most
- Niveus Medical, Inc.: 1 (https://510kreport.com/company/niveus-medical)
- Prospera Corporation: 1 (https://510kreport.com/company/prospera)
- Bio Protech, Inc.: 1 (https://510kreport.com/company/bio-protech)
- Mid-America Medical Innovations, LLC: 1 (https://510kreport.com/company/mid-america-medical-innovations)

## Its most-cited devices
- K102014: Tens Stimulator, Models 2800 and 3000 (2010), cited by 2
- K072795: Models Ems 5.0, Ems 5.1 (2007), cited by 1
- K080661: Models Tens 7000, Ems 7500 and Twin Stim (2008), cited by 1

## Recent decisions
- K102014: Tens Stimulator, Models 2800 and 3000 (Aug 31, 2010)
- K080661: Models Tens 7000, Ems 7500 and Twin Stim (Mar 24, 2008)
- K072795: Models Ems 5.0, Ems 5.1 (Nov 27, 2007)

Source page: https://510kreport.com/company/koalaty-products