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Heaxel

FDA UDI

Class II (US FDA UDI)

by Health Pixel Srl

Identity

Trade Name
Heaxel FDA UDI
Generic Name
Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
Device Name
Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders of patients with neuromotor disabilities. FDA UDI
Model / Reference
ICONE FDA UDI
Description
Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders of patients with neuromotor disabilities. FDA UDI

Identifiers

Primary DI / UDI-DI
08054329990001 FDA UDI
FDA Product Code
IKK FDA UDI
BXB FDA UDI
GMDN Term
Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1925 FDA UDI
890.5380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Virtual-display rehabilitation system, powered-support, upper-limb

Heaxel by Health Pixel Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Virtual-display rehabilitation system, powered-support, upper-limb.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Health Pixel Srl

Sources (1)

  • FDA UDI e05a05e0-3941-4066-9455-6f418b55cdd0 33 fields · synced Jun 6, 2026