CHATTEM, INC.

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Filters

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

Stimulator, Electrical, Transcutaneous, For Arthritis (NYN) (5) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (5)

Premarket Exempt

Clear

Icy Hot SmartRelief - 00041167080450 Catalog Number :

Device Description : Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back & Hip

Device Class : 2

Duns Number: 003336013

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

Icy Hot SmartRelief - 00041167080467 Catalog Number :

Device Description : Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back and Hip refill electrode

Device Class : 2

Duns Number: 003336013

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

Icy Hot SmartRelief - 00041167080474 Catalog Number :

Device Description : Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder

Device Class : 2

Duns Number: 003336013

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

Icy Hot SmartRelief - 00041167080498 Catalog Number :

Device Description : Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder refill electrode

Device Class : 2

Duns Number: 003336013

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

Icy Hot SmartRelief - 00041167080818 Catalog Number :

Device Description : Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Pack size - Back & Hip

Device Class : 2

Duns Number: 003336013

Premarket Exempt : No

Product Code : NUH, NYN

Prescription Use : No

Device Count : 1

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