Data / Medical devices / Pack, Hot Or Cold, Reusable

Pack, Hot Or Cold, Reusable (IME): 342 FDA-registered makers in 25 countries

342 establishments in 25 countries are registered with the FDA to make Pack, Hot Or Cold, Reusable (product code IME, Class 1, 21 CFR 890.5700). 1 of them has a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on April 14, 1993, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

IME

Device class

1

Regulation

890.5700

Medical specialty

Physical Medicine

Makers by country

Makers of Pack, Hot Or Cold, Reusable

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated April 14, 1993. 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.