ASSEMBLY REQUIRED DI

FDA Device Registration & Listing · Mount Sinai, NY, US · Registration 2437956

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
2437956
FEI Number
3002357954
Entity Name
ASSEMBLY REQUIRED DI
City/State/Country
Mount Sinai, NY, US
Establishment Address
5507 Nesconset Hwt. #10, Ste 336, Mount Sinai, NY 11766, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ASSEMBLY REQUIRED DIST. (Owner Number: 9031473)
Owner / Operator Contact Address
5507 Nesconset Hwy #10, --336, Mount Sinai, NY 11766, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K973418
PMA Number
N/A

All Registered Proprietary Names

CLM Instrument Trolley CLM Pillcrusher Qualine WC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRK Table, Instrument, Manual, Ophthalmic Ophthalmic Class 1 886.4855 2019-07-29
OHY Pill Crusher/Cutter General Hospital Class 1 880.6430 2013-06-11
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2007-12-05
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2007-12-05

Official Correspondent

DOREEN MURPHY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASSEMBLY REQUIRED DIST.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935211 Brookefield Hunter, Inc. WALK N CHAIR 1994-02-02
K832685 Health America WHEELCHAIR-VARIOUS MODELS 1983-09-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2437956. Last updated year: 2026. Please use registration number 2437956 when referencing this establishment in official correspondence.
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