XRHEALTH AMERICA INC

FDA Device Registration & Listing · Needham, MA, US · Registration 3041680548

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3041680548
FEI Number
3041680548
Entity Name
XRHEALTH AMERICA INC
City/State/Country
Needham, MA, US
Establishment Address
300 1st Ave Ste 103, Needham, MA 02494, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
XRHealth America Inc (Owner Number: 10094200)
Owner / Operator Contact Address
300 1st Ave, Ste 103, Needham, MA 02494, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

XRHealth VR CBT XRCogni XRReliever XRBehavior XRPhysio

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2025-11-18

Official Correspondent

Maya Bein Nachal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

XRHealth America Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041680548. Last updated year: 2026. Please use registration number 3041680548 when referencing this establishment in official correspondence.
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