SCOPE HEALTH

FDA Device Registration & Listing · New York, NY, US · Registration 3015534928

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
3015534928
FEI Number
3015534928
Entity Name
SCOPE HEALTH
City/State/Country
New York, NY, US
Establishment Address
79 Madison Avenue, New York, NY 10016, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Scope Health (Owner Number: 10060447)
Owner / Operator Contact Address
79 Madison Avenue, New York, NY 10016, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Optase Cooling Mask ComplEye Optase Moist Heat Mask

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2019-05-13
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2023-03-03
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2023-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Scope Health
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015534928. Last updated year: 2026. Please use registration number 3015534928 when referencing this establishment in official correspondence.
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