Primary Device ID | 07290016986143 |
NIH Device Record Key | 6ca83cb2-5137-409e-abed-e021a4077705 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VRCBT |
Version Model Number | AT-910 (Attention) |
Catalog Number | VRCBT AT-910 |
Company DUNS | 531893653 |
Company Name | VR HEALTH LTD |
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 | false |
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 |
Phone | +1 (857)-990-6111 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 07290016986143 [Primary] |
PTY | Computerized Cognitive Assessment Aid, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-23 |
Device Publish Date | 2021-06-15 |
07290016986136 - VRReliever | 2021-06-23 The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distracti |
07290016986143 - VRCBT | 2021-06-23The AT-910 ("A10tion") is a is a virtual reality, immersive therapeutic application, indicated to train and improve cognitive function of patients with diagnosed ADHD. This application is a clinician- monitored program and should be considered for use as part of the therapeutic program that include clinician directed therapy This multidimensional training program application targets attention, executive function and memory combined with motor activation through the use of games and entertainment features. |
07290016986143 - VRCBT | 2021-06-23 The AT-910 ("A10tion") is a is a virtual reality, immersive therapeutic application, indicated to train and improve cognitive fu |
07290016986075 - VRPhysio Home | 2020-04-20 A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics a |
07290016986129 - VRReliever | 2020-04-20 The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and physical discomfort through distractio |
07290016986099 - VRPhysio Home | 2020-04-20 A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics a |
07290016986082 - VRPhysio Home | 2020-04-20 A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movemen |
07290016986068 - VRReliever | 2020-04-20 The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and |
07290016986112 - VRCogni | 2020-01-07 A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitiv |