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Digital Therapist

FDA UDI

Class II (US FDA UDI)

by Sword Health, S.a.

Identity

Trade Name
Digital Therapist FDA UDI
Generic Name
Virtual-display rehabilitation system, non-supportive, home-use FDA UDI
Model / Reference
SWORDPhoenix-14 FDA UDI

Identifiers

Primary DI / UDI-DI
05600775530143 FDA UDI
FDA Product Code
ISD FDA UDI
GMDN Term
Virtual-display rehabilitation system, non-supportive, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5360 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

No

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, non-supportive, home-use

Digital Therapist by Sword Health, S.a. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Virtual-display rehabilitation system, non-supportive, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sword Health, S.a.

Sources (1)

  • FDA UDI 90c2426f-f762-4c83-8966-a8642064c6a2 32 fields · synced May 31, 2026