Icy Hot SmartRelief

GUDID 00041167080818

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

CHATTEM, INC.

Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00041167080818
• NIH Device Record Key: 3331461e-be54-4a91-9823-b0d915894cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icy Hot SmartRelief
• Version Model Number: SmartRelief 1.0 - Club Pack
• Company DUNS: 003336013
• Company Name: CHATTEM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041167080818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131159

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-02-19
• Device Publish Date: 2016-09-15

On-Brand Devices [Icy Hot SmartRelief]

• 00041167080818: Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Pack size - Back
• 00041167080498: Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder ref
• 00041167080474: Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder
• 00041167080467: Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back and Hip refill e
• 00041167080450: Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back & Hip