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Data / Medical devices / Pack, Hot Or Cold, Water Circulating / United States

FDA-registered makers of Pack, Hot Or Cold, Water Circulating in the United States: 46 establishments

46 establishments in the United States are registered with the FDA to make Pack, Hot Or Cold, Water Circulating (product code ILO). 4 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device
Pack, Hot Or Cold, Water Circulating
Product code
ILO
Country
United States

Makers of Pack, Hot Or Cold, Water Circulating in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Adroit Medical Systems, Inc.Loudon, TN, United StatesManufacturer1September 10, 1997000api.fda.gov
Bio Compression Systems, Inc.Moonachie, NJ, United StatesManufacturer1October 28, 1996000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer1October 24, 1991020api.fda.gov
C2Dx, Inc.Schoolcraft, MI, United StatesComplaint file establishment, Manufacturer, Specification developer1May 8, 2008000api.fda.gov
Advanced Ambulatory, IncHouston, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
All Quality & Services, Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
All Quality & Services, Inc.Garland, TX, United StatesContract manufacturer0000api.fda.gov
Aquilo Sports L.L.C.Louisville, KY, United StatesSpecification developer0000api.fda.gov
Ascentron, Inc.White City, OR, United StatesContract manufacturer0000api.fda.gov
Agiliti Health - CoronaCorona, CA, United StatesContract manufacturer0000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Brace AlignSoddy Daisy, TN, United StatesSpecification developer0000api.fda.gov
Comfortland International, LLCMebane, NC, United StatesSpecification developer0000api.fda.gov
Cryo-Dynamics Inc.Southlake, TX, United StatesManufacturer0000api.fda.gov
Cryodressing, IncHouston, TX, United StatesManufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer0020api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0010api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer0000api.fda.gov
Ermi LLCAtl, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Gener8San Jose, CA, United StatesContract manufacturer0000api.fda.gov
Gentherm Medical, LLCCincinnati, OH, United StatesManufacturer0060api.fda.gov
Imex, LLCFulton, MD, United StatesManufacturer0000api.fda.gov
Innovative Medical EquipmentBeachwood, OH, United StatesSpecification developer0000api.fda.gov
Ivy TechnologyJeffersontown, KY, United StatesContract manufacturer0000api.fda.gov
Joicom CorporationEastvale, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
KelviInglewood, CA, United StatesManufacturer0000api.fda.gov
Medical Quant UsaSolon, OH, United StatesSpecification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nice Recovery Systems LLCBoulder, CO, United StatesManufacturer0000api.fda.gov
Normatec Industries, LPWatertown, MA, United StatesSpecification developer0000api.fda.gov
Onlycare IncDenver, CO, United StatesManufacturer0000api.fda.gov
Polar Products IncStow, OH, United StatesManufacturer0000api.fda.gov
Polo Custom ProductsMonticello, IA, United StatesContract manufacturer0000api.fda.gov
Polo Custom ProductsTopeka, KS, United StatesContract manufacturer0000api.fda.gov
PRIDE IndustriesRoseville, CA, United StatesContract manufacturer0000api.fda.gov
R2 Technologies, Inc.Dublin, CA, United StatesManufacturer0000api.fda.gov
Rechar Inc.Strasburg, CO, United StatesManufacturer0000api.fda.gov
Thermotek, Inc.Flower Mound, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Ultra Pain Products, Inc.Albertson, NY, United StatesSpecification developer0000api.fda.gov
Unite Medical, LLCLithia Springs, GA, United StatesSpecification developer0000api.fda.gov
VIVE Health LLCNaples, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Vonco Products, LLCFortville, IN, United StatesContract manufacturer0000api.fda.gov
Zenith Technical Innovations, LLCGurnee, IL, United StatesManufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.