Primary Device ID | 04041925002805 |
NIH Device Record Key | 7cb6e35c-0aa9-4811-a2fb-dd63cb4c16db |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OmniStand |
Version Model Number | A000-509 |
Company DUNS | 828331616 |
Company Name | ACCELERATED CARE PLUS CORP |
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 | false |
Serial Number | true |
Manufacturing Date | false |
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 | 04041925002805 [Primary] |
PKS | Exerciser, Non-Measuring For Stroke Rehabilitation |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-11 |
Device Publish Date | 2023-09-01 |
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B179OMNI13E87E4 - OmnisEMG | 2023-09-14 Biomechanical function analysis / interactive rehabilitation system |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OMNISTAND 87024401 5459603 Live/Registered |
Hanger, Inc. 2016-05-04 |
OMNISTAND 85519514 4183410 Live/Registered |
RadTech, LLC 2012-01-18 |