FDA device listing

Achilles Pack,Ankle Pack,Calf/Shin Pack,Cold Pocket,Cold Slipper,Dorsum Pack,Foot Pain Cold Pack,Natural Therapeutic Oat…

FDA device listing 1267497841 · Rapid Aid Corp.

Key facts

Proprietary names Achilles Pack,Ankle Pack,Calf/Shin Pack,Cold Pocket,Cold Slipper,Dorsum Pack,Foot Pain Cold Pack,Natural Therapeutic Oat bag,Plantar Pack,Reusable Cold Gel Pack,Reusable Hot & Cold Compress Wrap,Reusable Hot & Cold Gel Pack
Owner/operator Rapid Aid Corp.
Owner/operator number 10028086
Product codes IME
Device names IME - Pack, Hot Or Cold, Reusable
Device class Class I
Classification regulations (21 CFR) 890.5700
Review panels Physical Medicine
Registered establishments Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd, Rapid Aid Corp., RAPID AID CORP., Rapid Aid Vietnam Co., Ltd
Establishment registrations 9710505, 3008955719, 3010039589, 3014982528, 3038103734
FEI numbers 3003339304, 3008955719, 3010039589, 3014982528, 3038103734
Establishment operations Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Manufacturer, Foreign Private Label Distributor
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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