# Hygia Health Services, Inc.

- Location (FDA's records): Birmingham, AL
- FDA decisions: 14 (2002–2010): 14 510(k) clearances
- Product codes: JOW (9), NLF (3), NMD (1), NPP (1)
- Predicates its devices cite: 38 (8 its own); citations of its devices by later devices: 28 (8 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
- Somanetics Corp.: 6 (https://510kreport.com/company/somanetics)
- Compression Therapy Concepts, Inc.: 3 (https://510kreport.com/company/compression-therapy-concepts)
- Huntleigh Healthcare, Inc.: 2 (https://510kreport.com/company/huntleigh-healthcare)
- Healthcare Service and Supply: 2 (https://510kreport.com/company/healthcare-service-and-supply)
- Microtek Medical, Inc.: 2 (https://510kreport.com/company/microtek-medical)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Advanced Instruments, Inc.: 1 (https://510kreport.com/company/advanced-instruments)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)

## Firms that cite its devices most
- Midwest Reprocessing Center, LLC: 12 (https://510kreport.com/company/midwest-reprocessing-center)
- Renu Medical, Inc.: 7 (https://510kreport.com/company/renu-medical)
- Wmi Enterprises, LLC: 1 (https://510kreport.com/company/wmi-enterprises)

## Its most-cited devices
- K012417: Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480 (2002), cited by 4
- K012654: Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20, DVT 30, DVT 40 (2002), cited by 4
- K012650: Hygia Health Services Reprocessed Nutech Foot Wrap (2002), cited by 3
- K012651: Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 (2002), cited by 3
- K021509: Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089 (2002), cited by 3
- K041867: Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N (2004), cited by 2

## Recent decisions
- K100523: Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM, HHS-SPFB-Usa (May 4, 2010)
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (Apr 22, 2009)
- K080424: Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and HHS-1861 (May 28, 2008)
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs (Feb 15, 2006)
- K041867: Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N (Sep 10, 2004)
- K032821: Hygia Health Services Reprocessed Blood Pressure Cuff (Dec 5, 2003)
- K012715: Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II (Aug 1, 2003)
- K021509: Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089 (Dec 24, 2002)

Source page: https://510kreport.com/company/hygia-health-services