| Primary Device ID | 20815991020340 |
| NIH Device Record Key | f6bc6d12-c463-4dc3-9b39-4b43f96dd38e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENSRX |
| Version Model Number | NPPELE615 |
| Catalog Number | 615 |
| Company DUNS | 066689993 |
| Company Name | BOXOUT, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com | |
| Phone | 866-528-2152 |
| info@bodysportproducts.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815991020346 [Primary] |
| GS1 | 10815991020343 [Package] Contains: 00815991020346 Package: Inner box [65 Units] In Commercial Distribution |
| GS1 | 20815991020340 [Package] Contains: 10815991020343 Package: Master Carton [8 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2016-09-05 |
| 00815991020353 | TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE |
| 20815991020340 | TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 500/CASE |