| Primary Device ID | 00082161605003 |
| NIH Device Record Key | 17c387ad-4a7f-4de0-97af-b9a6cd27e5bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMAK RSI |
| Version Model Number | 60500 |
| Company DUNS | 091999771 |
| Company Name | BROWNMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00082161605003 [Primary] |
| IRA | Hand, External Limb Component, Mechanical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-03 |
| Device Publish Date | 2020-08-26 |
| 00649833201651 | Smart Glove w/Thumb |
| 00649833201637 | Smart Glove w/Thumb |
| 00649833201620 | Smart Glove w/Thumb |
| 00649833201613 | Smart Glove w/Thumb |
| 00649833201286 | Computer Glove |
| 00649833201279 | Smart Glove |
| 00649833201262 | Smart Glove |
| 00649833201255 | Smart Glove |
| 00649833201118 | Smart Glove |
| 00649833101111 | Smart Glove PM |
| 00649833103122 | Pil-O-Splint |
| 00649833103016 | Elbow Band |
| 00649833101722 | Elbow Support PM |
| 00649833101135 | Elbow Support |
| 00649833101128 | Pil-O-Splint |
| 00082161605003 | WRISTIMER PM® |
| 00082161600206 | WRISTIMER® |
| 00082161600107 | WRISTIMER® |
| 00082161600008 | WRISTIMER® |
| 00649833301412 | Arm Sling with Immobilizer |
| 00649833301405 | Arm Sling |
| 00649833301375 | Knee Strap |