| Primary Device ID | 05065012458138 |
| NIH Device Record Key | 96f9596d-e4e8-4b7c-b4ef-5a8a3d1fa89e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Strolll Rehab |
| Version Model Number | ML2 v1.0 |
| Catalog Number | Strolll-REHAB-0001-ML2 |
| Company DUNS | 224725541 |
| Company Name | STROLLL LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co | |
| Phone | +1 440-201-4074 |
| customerservice@strolll.co |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05065012458138 [Primary] |
| QKC | Interactive Rehabilitation Exercise Device, Prescription Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-24 |
| Device Publish Date | 2025-12-16 |
| 05065012458138 - Strolll Rehab | 2025-12-24Strolll Rehab is a device to help and improve mobility in states of physical impairment caused by neurological conditions including Parkinson’s disease, stroke, multiple sclerosis, Traumatic Brain Injury and other neurological disorders affecting movement. It uses augmented reality in a head-mounted display, presenting visual and audible cues to the user, as well as rehabilitation exercise games for physical therapy. The software is intended to complement traditional rehabilitation and is used under the supervision of a therapist (synchronously or asynchronously). The Strolll Portal is used by healthcare professionals to manage patient therapy and oversee engagement. |
| 05065012458138 - Strolll Rehab | 2025-12-24 Strolll Rehab is a device to help and improve mobility in states of physical impairment caused by neurological conditions includ |
| 05065012458114 - Reality DTx | 2024-07-16 A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological c |
| 05065012458121 - Reality DTx | 2024-07-16 A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological c |
| 05065012458039 - Reality DTx | 2023-08-30 A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological c |
| 05065012458046 - Reality DTx | 2023-08-30 A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological c |