FDA device listing

Carepeutic: KH265-V02,Carshion: C245103.C245104 Heated Seat Cushion: C245101 Heated Seat Cover,Eye…

FDA device listing 2034313868 · Zhangzhou Easepal Innovation Co.,Ltd

Key facts

Proprietary names Carepeutic: KH265-V02,Carshion: C245103.C245104 Heated Seat Cushion: C245101 Heated Seat Cover,Eye Massager:LF-ME001-TPK,LF-ME001-TWT,LS-ME001-JPK,Foot Massager:LFF001-OSCO,Homedics:B-FMS-1000HJ FS1 Shiatsu Foot Massager with heat,Homedics:B-NMS-229J Shiatsu Neck Massager,Homedics:FMS-370HJ,Homedics:HCM-350HJ-2 Weighted Massager Wrap with shooting heat,Homedics:HHP-735HJ Percussion…
Owner/operator Zhangzhou Easepal Innovation Co.,Ltd
Owner/operator number 10069598
Product codes ISA
Device names ISA - Massager, Therapeutic, Electric
Device class Class I
Classification regulations (21 CFR) 890.5660
Review panels Physical Medicine
Registered establishments ZHANGZHOU EASEPAL INNOVATION CO.,LTD
Establishment registrations 3017103444
FEI numbers 3017103444
Establishment operations Contract Manufacturer, Manufacturer
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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