Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027797

FEI Number

1000125727

Entity Name

21ST CENTURY SCIENTIFIC, INC.

City/State/Country

Coeur D Alene, ID, US

Establishment Address

4931 N Manufacturing Way, Coeur D Alene, ID 83815, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

21ST CENTURY SCIENTIFIC, INC. (Owner Number: 9000697)

Owner / Operator Contact Address

4931 N Manufacturing Way, --, Coeur D Alene, ID 83815, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193599

PMA Number

N/A

All Registered Proprietary Names

BOUNDER MANUAL GURNEY BOUNDER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2021-10-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2021-07-16

Official Correspondent

Ronald Davidson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

21ST CENTURY SCIENTIFIC, INC.

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
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

Similar Registrations

Registration Number	Establishment Name	Location
8022103	TECHLEM MEDICAL CORP.	MISSISSAUGA Ontario, CA
2184033	ELECTRO-CONNECT, INC.	Milwaukee, WI, US
1033902	FUTURE HEALTH CONCEPTS, INC.	Sanford, FL, US
3007744192	HEBEI PUKANG MEDICAL INSTRUMENTS CO.,LTD	Baoding Hebei, CN
3003674698	MedSource Labs, LLC	Chanhassen, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027797. Last updated year: 2026. Please use registration number 2027797 when referencing this establishment in official correspondence.