| Primary Device ID | 00858703006115 |
| NIH Device Record Key | 557f8f9a-7762-4f41-ac3f-d4873f98d817 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnistim FX2 Cycle/Walk Portable |
| Version Model Number | 300400A |
| Company DUNS | 828331616 |
| Company Name | ACCELERATED CARE PLUS CORP |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858703006115 [Primary] |
| GS1 | 00858703006116 [Package] Package: Case [10 Units] In Commercial Distribution |
| IPF | Stimulator, Muscle, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-03-10 |
| Device Publish Date | 2016-08-16 |
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