Heaxel ICONE
Heaxel ICONE is a virtual-display rehabilitation system (FDA Class II) made by Health Pixel SRL, listed in FDA GUDID since 7 Aug 2020 (UDI-DI 08054329990001), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08054329990001 | Date7 Aug 2020 | StatusListed |
Official records
- AccessGUDID record 08054329990001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Heaxel
- Generic name
- Virtual-display rehabilitation system, powered-support, upper-limb
- Model / reference
- ICONE
- Primary DI / UDI-DI
- 08054329990001
- FDA product code
- IKK, BXB
- GMDN term
- Virtual-display rehabilitation system, powered-support, upper-limb
- Device class
- Class II
- Regulation number
- 890.1925, 890.5380
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IKK (System, Isokinetic Testing And Evaluation).
- BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP by Biodex Medical Systems
- LIDO(TM) WORKSET by Loredan Biomedical, Inc.
- Lower extremity intelligent feedback training system for children A1mini Rocket version by Guangzhou Yikang Medical Equipment Industrial Co., Ltd
- DEXTER ISOKINETIC by Cedaron Medical, Inc.
- Lower extremity intelligent feedback training system for children A1mini Deer version by Guangzhou Yikang Medical Equipment Industrial Co., Ltd
- TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR by Biodan Medical Systems, Ltd.
- LIDO ACTIVE by Loredan Biomedical, Inc.
- Eccentron LE1 by BTE TECHNOLOGIES, INC.
- NAUTILUS LEG EXTENSION TESTING & REHABILITATION by Nautilus Sports/Medical Industries, Inc.
- CYBEX 340 by Cybex