Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016598690

FEI Number

3016598690

Entity Name

HORST ENTERPRISES INC

City/State/Country

Saint Petersburg, FL, US

Establishment Address

4800 95th Street N., Saint Petersburg, FL 33708, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Horst Enterprises Inc (Owner Number: 10062848)

Owner / Operator Contact Address

4800 95th Street N., Saint Petersburg, FL 33708, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wheelchair Footrest Brake Extentions Proline Homecare Bed Anti tippers Proline Cane Transport Chair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2020-03-11
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2020-03-11
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2020-03-11
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2020-03-11
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2020-03-11
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2020-03-11
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2020-03-11
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2020-03-11

Official Correspondent

Darrin Horst

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Horst Enterprises 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.

Similar Registrations

Registration Number	Establishment Name	Location
3007309323	ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD	ZHENJIANG CITY Jiangsu, CN
3007608806	PRIDE MOBILITY PRODUCTS CORP.	North Las Vegas, NV, US
3004473024	STEALTH PRODUCTS	BURNET, TX, US
9616881	HEARTWAY MEDICAL PRODUCTS CO., LTD.	TAICHUNG CITY, TW
3009303347	PERMOBIL (KUNSHAN) CO., LTD	Kunshan Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016598690. Last updated year: 2026. Please use registration number 3016598690 when referencing this establishment in official correspondence.