Hayswell

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pad, Heating, Powered (IRT) (1)

Premarket Exempt

Yes

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HAYSWELL - 00860036001101 Catalog Number :

Device Description : Powered heating pad.An assembly of mains electricity (AC-powered) devices design Powered heating pad.An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

Device Class : 2

Duns Number: 017094867

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

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