# Prizm Medical, Inc.

- Location (FDA's records): Dunwoody, GA
- FDA decisions: 8 (1994–2014): 8 510(k) clearances
- Product codes: IPF (2), NUH (2), GXY (2), GYB (1), FLL (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 13 (3 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
- Axelgaard Mfg. Co., Ltd.: 1 (https://510kreport.com/company/axelgaard-mfg)
- Hollywog, LLC: 1 (https://510kreport.com/company/hollywog)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Uni-Patch, Inc.: 1 (https://510kreport.com/company/uni-patch)
- Parker Laboratories, Inc.: 1 (https://510kreport.com/company/parker-laboratories)
- Woodside Biomedical, Inc.: 1 (https://510kreport.com/company/woodside-biomedical)

## Firms that cite its devices most
- Newmark, Inc.: 2 (https://510kreport.com/company/newmark)
- Neurotron Medical: 2 (https://510kreport.com/company/neurotron-medical)
- Endurance Therapeutics: 1 (https://510kreport.com/company/endurance-therapeutics)
- Everyway Medical Instruments Co.,Ltd: 1 (https://510kreport.com/company/everyway-medical-instruments)
- Carol Cole Company: 1 (https://510kreport.com/company/carol-cole)
- Newwave Medical, LLC: 1 (https://510kreport.com/company/newwave-medical)
- Hi-Dow International, Inc.: 1 (https://510kreport.com/company/hi-dow-international)
- Well-Life Healthcare Limited: 1 (https://510kreport.com/company/well-life-healthcare)

## Its most-cited devices
- K033122: 5000Z System (Otc) (2004), cited by 7
- K932299: Electro-Mesh (1994), cited by 2
- K024181: Prizm Medical, Inc. Micro-Z Stimulation System (2003), cited by 1
- K944487: Electro-Mesh Sock, Wrap, and Sleeve Electrodes (1995), cited by 1
- K951727: Z-Watch System (1995), cited by 1
- K032239: Thera-Cream, Model TCT004 (2004), cited by 1

## Recent decisions
- K133502: 5000Z Firefly System (Dec 3, 2014)
- K033122: 5000Z System (Otc) (Aug 25, 2004)
- K032239: Thera-Cream, Model TCT004 (Jul 30, 2004)
- K024181: Prizm Medical, Inc. Micro-Z Stimulation System (Jun 26, 2003)
- K012974: Prizm Medical Inc. Thermotrace Infrared Thermometer Models 15004 and 15007 (Jul 23, 2002)
- K951727: Z-Watch System (Nov 21, 1995)
- K944487: Electro-Mesh Sock, Wrap, and Sleeve Electrodes (Feb 21, 1995)
- K932299: Electro-Mesh (Jul 1, 1994)

Source page: https://510kreport.com/company/prizm-medical