Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007913191

FEI Number

3007913191

Entity Name

NINGBO HECAI MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Kesan Road, Ninghai Economic and Development Zone, Ningbo Zhejiang 315600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Ningbo Hecai Medical Equipment Co.,Ltd. (Owner Number: 10043657)

Owner / Operator Contact Address

Kesan Road, Ninghai Economic and Development Zone, Ningbo, CN-ZJ 315600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trolley Rolyan Exercise Pinch Clip Tub Rolyan Graded Pinch Exerciser LS-EA5003C, LS-EA7009, LS-EA5029, LS-EA5019, LS-EA5019B, LS-EA4010, LS-EA5003C ELECTRIC PEDIATRIC BED LS-EA9005

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2017-01-09
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2017-01-09
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2013-03-08
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-03-08
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2015-03-02
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-03-08
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2013-03-08

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Ningbo Hecai Medical Equipment Co.,Ltd.

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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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

Similar Registrations

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9615415	PRIME PACIFIC HEALTH INNOVATIONS CORPORATION	PORT COQUITLAM British Columbia, CA
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
1063324	REACT Innovations	Charlotte, NC, US
3043460907	Drive DeVilbiss Healthcare	Perris, CA, US
3005214422	HOMECARE ENTERPRISE CO., LTD.	Changhua City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007913191. Last updated year: 2026. Please use registration number 3007913191 when referencing this establishment in official correspondence.