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XR Therapy System PSL

by Neuromersive, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860004615606 UDI-DI Date25 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
XR Therapy System
Generic Name
Virtual-display rehabilitation system, non-supportive, clinical
Model / Reference
PSL
Primary DI / UDI-DI
00860004615606
FDA Product Code
ISD
GMDN Term
Virtual-display rehabilitation system, non-supportive, clinical
Device Class
Class II
Regulation Number
890.5360
GUDID distribution status
In Commercial Distribution

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No