| Primary Device ID | B872ITBK440 |
| NIH Device Record Key | b166ec8a-6809-4b39-aa11-2b19500a7803 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intelligent Textile Stim-Support Back Wrap |
| Version Model Number | ITBK44 |
| Company DUNS | 790271118 |
| Company Name | PRIZM MEDICAL, 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B872ITBK440 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-17 |
| Device Publish Date | 2024-06-07 |
| B872ITBK440 - Intelligent Textile Stim-Support Back Wrap | 2024-06-17Intelligent Textile Stim-Support Back Wrap Kit |
| B872ITBK440 - Intelligent Textile Stim-Support Back Wrap | 2024-06-17 Intelligent Textile Stim-Support Back Wrap Kit |
| B872SSELBW0 - Stim-Support Elbow Brace | 2024-06-17 Stim-Support Elbow Brace Kit |
| B872SSKNEE0 - Stim-Support Knee Brace | 2024-06-17 Stim-Support Knee Brace Kit |
| B872SSNECK0 - Stim-Support Neck Brace | 2024-06-17 Stim-Support Neck Brace Kit |
| B872SSSHLD0 - Stim-Support Shoulder Brace | 2024-06-17 Stim-Support Shoulder Brace Kit |
| B872EMG20130 - Electro-Mesh Glove | 2024-06-14 Electro-Mesh Glove - Medium |
| B872EMSP240 - Electro-Mesh Panel | 2024-06-14 Electro-Mesh Panel 1.5x4 |
| B872EMSP440 - Electro-Mesh Panel | 2024-06-14 Electro-Mesh Panel 4x4 |