Reletex PCN3

GUDID 20661168300018

Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient use.

RELIEFBAND TECHNOLOGIES LLC

Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband Anti-nausea transcutaneous electrical nerve stimulation wristband

• Primary Device ID: 20661168300018
• NIH Device Record Key: dc4ec6d2-94cb-4e4e-a58d-ee702a65b2e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reletex
• Version Model Number: PCN3
• Catalog Number: PCN3
• Company DUNS: 080294073
• Company Name: RELIEFBAND TECHNOLOGIES LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com
• Phone: 9999999999
• Email: gudidservice@reliefband.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00661168300014 [Primary]
GS1	10661168300011 [Package]; Package: Master [8 Units]; In Commercial Distribution
GS1	20661168300018 [Package]; Contains: 00661168300014; Package: Inner [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994387

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-07
• Device Publish Date: 2021-06-29

Devices Manufactured by RELIEFBAND TECHNOLOGIES LLC

• 00661168190011 - Reliefband® Conductivity Gel: 2021-07-07 Reliefband Conductivity Gel for use with Reliefband devices. Each tube contains 7.5 mL (0.25 oz) of hypoallergenic conductivity
• 20661168300018 - Reletex: 2021-07-07Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient use.
• 20661168300018 - Reletex: 2021-07-07 Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses
• 20661168600019 - Reliefband® Classic: 2021-07-07 Reliefband® Classic is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is wor
• 30661168600023 - Reliefband® Premier Charcoal: 2021-07-07 Reliefband® Premier Charcoal is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallerge
• 30661168600030 - Reliefband® Premier Slate Blue: 2021-07-07 Reliefband® Premier Slate Blue is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoaller
• 00661168800019 - Reliefband® Custom USB Charging Cable: 2021-07-07 Reliefband Custom USB Charging Cable is specifically designed for the Reliefband Premier devices and is one meter in length. The