# Empi

- Location (FDA's records): Arden Hills, MN
- FDA decisions: 60 (1977–2010): 60 510(k) clearances
- Product codes: GZJ (17), EGJ (11), GXY (10), KPI (8), IPF (8), HIR (2), GZI (1), LIH (1), BXB (1), KGX (1)
- Predicates its devices cite: 60 (39 its own); citations of its devices by later devices: 82 (39 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
- Iomed, Inc.: 6 (https://510kreport.com/company/iomed)
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Chattanooga Group, Inc.: 2 (https://510kreport.com/company/chattanooga-group)
- Motion Control, Inc.: 2 (https://510kreport.com/company/motion-control)
- Verimed Holdings, Inc.: 2 (https://510kreport.com/company/verimed-holdings)
- Jace Systems, Inc.: 1 (https://510kreport.com/company/jace-systems)
- Rs Medical: 1 (https://510kreport.com/company/rs-medical)
- Ryan Telemedicine: 1 (https://510kreport.com/company/ryan-telemedicine)

## Firms that cite its devices most
- Vertis Neuroscience, Inc.: 4 (https://510kreport.com/company/vertis-neuroscience)
- Lorenz Biotech S.P.A.: 2 (https://510kreport.com/company/lorenz-biotech)
- Activatek, Inc.: 2 (https://510kreport.com/company/activatek)
- Djo, LLC: 2 (https://510kreport.com/company/djo)
- Selectivemed Components, Inc.: 2 (https://510kreport.com/company/selectivemed-components)
- Ibramed Equipamentos Medicos: 2 (https://510kreport.com/company/ibramed-equipamentos-medicos)
- Newlife Sciences, LLC: 1 (https://510kreport.com/company/newlife-sciences)
- Xanacare Technologies, LLC: 1 (https://510kreport.com/company/xanacare-technologies)

## Its most-cited devices
- K021100: 300 PV Complete Electrotherapy System (2002), cited by 10
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode (1998), cited by 8
- K061650: Select Tens, Model 4600S (2007), cited by 7
- K951951: Focus Model 795 Unit (1996), cited by 6
- K970203: Epix VT (1997), cited by 5
- K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3 (1991), cited by 4

## Recent decisions
- K093324: Empi Continuum (Mar 5, 2010)
- K090922: Empi Active Transcutaneous Nerve Stimulator (Jun 5, 2009)
- K072946: Hybresis Iontophoresis Drug Delivery System (Nov 16, 2007)
- K070427: Dupel Transport Iontophoresis System (May 14, 2007)
- K061650: Select Tens, Model 4600S (Jan 22, 2007)
- K041920: Infinity Plus Electrotherapy System (Jan 21, 2005)
- K042057: Infinity Electrotherapy System (Dec 17, 2004)
- K030395: Empi Action Patch Iontophoresis System (Apr 8, 2003)

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