ELITE MEDICAL SUPPLY OF NEW YORK, LLC

FDA Device Registration & Listing · Hendersonville, TN, US · Registration 3013375723

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
3013375723
FEI Number
3013375723
Entity Name
ELITE MEDICAL SUPPLY OF NEW YORK, LLC
City/State/Country
Hendersonville, TN, US
Establishment Address
40-C Industrial Park Drive, Hendersonville, TN 37075, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Elite Medical Supply of New York, LLC (Owner Number: 10039893)
Owner / Operator Contact Address
1900 RIDGE ROAD, West Seneca, NY 14224, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Elite Multi Mode Stimulator Kit Elite 637/650 LSO Elite 456/457 TLSO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2012-02-19
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2024-09-13
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2024-09-13

Official Correspondent

Gary Nikiel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elite Medical Supply of New York, LLC
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
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

Similar Registrations

Registration Number Establishment Name Location
3020683829 SUZHOU FAST ATM ELECTRIC CO., LTD Suzhou Jiangsu, CN
3005344585 ODSTOCK MEDICAL LTD SALISBURY Wiltshire, GB
3038295706 JUST KEEP HEALTHY CO., LTD. Samkkei Munichay District Kampong Speu, KH
3019892999 CIONIC Facility Scotts Valley, CA, US
3012316249 COMPASS HEALTH BRANDS (CORPORATE OFFICE) Middleburg Heights, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013375723. Last updated year: 2026. Please use registration number 3013375723 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.