Reliefband® Flex
GUDID 00661168000174
Reliefband® Flex is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 350+ hours of active use at power level 3 or below. The batteries of Reliefband® Flex are user replaceable. Replace batteries in unit when they become drained.
RELIEFBAND TECHNOLOGIES LLC
Anti-nausea transcutaneous electrical nerve stimulation wristband| Primary Device ID | 00661168000174 |
| NIH Device Record Key | b3819c50-95df-4f45-a633-55059d46b60b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reliefband® Flex |
| Version Model Number | RBFLX |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com | |
| Phone | 9999999999 |
| gudidservice@reliefband.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00661168000174 [Primary] |
| GS1 | 10661168000171 [Package] Package: Inner [12 Units] In Commercial Distribution |
| GS1 | 20661168000178 [Package] Contains: 10661168000171 Package: Master [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191547
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 | 2025-03-04 |
| Device Publish Date | 2025-02-24 |
Devices Manufactured by RELIEFBAND TECHNOLOGIES LLC
| 30661168800010 - Reliefband® Sport - Black | 2025-03-04 Reliefband® Sport is a rechargeable, digital therapeutic device that has stimulating electrodes and is worn on the underside of |
| 30661168800027 - Reliefband® Sport - Soft Grey | 2025-03-04 Reliefband® Sport is a rechargeable, digital therapeutic device that has stimulating electrodes and is worn on the underside of |
| 10661168000164 - Reliefband® 50 Hours | 2025-03-04 Reliefband® 50 Hours is a therapeutic device incorporated into a wristband which has stimulating electrodes that is worn on the |
| 00661168000174 - Reliefband® Flex | 2025-03-04Reliefband® Flex is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 350+ hours of active use at power level 3 or below. The batteries of Reliefband® Flex are user replaceable. Replace batteries in unit when they become drained. |
| 00661168000174 - Reliefband® Flex | 2025-03-04 Reliefband® Flex is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn o |
| 10661168000188 - Reliefband® Premier Plus | 2025-03-04 Reliefband® Premier Plus is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic |
| 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 | 2021-07-07 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 |
Trademark Results [Reliefband]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIEFBAND 88161362 not registered Dead/Abandoned |
ReliefBand Technologies, LLC 2018-10-19 |
 RELIEFBAND 78645971 3260073 Live/Registered |
ReliefBand Technologies LLC 2005-06-08 |
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