Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003771601

FEI Number

3003771601

Entity Name

ARCHE HEALTHCARE

City/State/Country

Pound Ridge, NY, US

Establishment Address

23 Split Rock Road, Pound Ridge, NY 10576, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Arche Healthcare (Owner Number: 10025074)

Owner / Operator Contact Address

23 Split Rock Road, Pound Ridge, NY 10576, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080816

PMA Number

N/A

All Registered Proprietary Names

VibraTip DermaStat PressureStat TempStat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2012-07-16
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-11-07
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2008-03-12
OIZ	Foot Examination Tool For Inflammatory Changes	Physical Medicine	Class 1	890.5050	2010-02-04

Official Correspondent

Scott Kantro

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arche Healthcare

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003771601. Last updated year: 2026. Please use registration number 3003771601 when referencing this establishment in official correspondence.