Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016590299

FEI Number

3016590299

Entity Name

HI-LIFE TECHNOLOGY (HEBEI) CO.,LTD.

City/State/Country

Bazhou Hebei, CN

Establishment Address

67.2 KM OF THE SOUTH OF NO.112 HIGHWAY, Bazhou Hebei 065700, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HI-LIFE TECHNOLOGY (HEBEI) CO.,LTD. (Owner Number: 10062700)

Owner / Operator Contact Address

67.2 KM OF THE SOUTH OF NO.112 HIGHWAY, Bazhou, CN-HE 065700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HL-B211B, HL-B211C, HL-B210A, HL-B210B, HL-B210C, HL-B210D Electric Hospital Bed; HL-B117A, HL-B117B, HL-B117C, HL-B117D, HL-B115A, HL-B115B, HL-B115C, HL-B115D, HL-B211A, Mattress HL-D1411A, HL-D1411B, HL-D1411C, HL-D1412A, HL-D1412B, HL-D1412C Electric Operating Table, Electric Delivery Bed HL-B320A, HL-B320B, HL-B330A, HL-B330B, HL-B220A, HL-B221A, HL-B340A, HL-B340B, HL-B320C, HL-B320D Hospital Trolley Surgical Head Support Lateral Position Fixing System Surgical Lithotomy stirrup Leg Holders HL-A1101A, HL-A1101B HL-A411A, HL-A411B, HL-A412A, HL-A412B, HL-A1001A, HL-A1001B, HL-A1002A, HL-A1002B, HL-A910A, HL-A910B, HL-A910C, Operating Lamp HL-A1311A, HL-A1311B, HL-A1311C, HL-B1321A, HL-B1321B, HL-B1321C, XH610L Electric examination table; HL-B181A, HL-B181B, HL-B181C, HL-B181D, HL-B182A, HL-B182B, HL-B182C, HL-B182D, HL-B183A, HL-B183B, HL-B183C, HL-B183D, HL-B250A, HL-B250B, HL-B250C, HL-B250D, HL-B250E, HL-B250F, HL-B250G. Patient hoist; HL-A491A, HL-A491B, HL-A491C, HL-A491D. Surgical Positioning Pad,Patient Return Electrode Pad HL-A8124E, HL-A8124F, HL-A8124G, HL-A8124H, HL-A8124I, HL-A8124J, HL-A8124K, HL-A8124L, HL-A8124M, HL-A8124N, HL-A8124O, HL-A8117H, HL-A8117I, HL-A8117J, HL-A8118A, HL-A8118B, HL-A8118C, HL-A8118D, HL-A8118E, HL-A8118F, HL-A8118G, HL-A8118H, HL-A8121V, HL-A8121W, HL-A8121X, HL-A8121Y, HL-A8121Z, HL-A8122A, HL-A8122B, HL-A8122C, HL-A8122D, HL-A8123A, HL-A8123B, HL-A8120E, HL-A8121A, HL-A8121B, HL-A8121C, HL-A8121D, HL-A8121E, HL-A8121F, HL-A8121G, HL-A8121H, HL-A8121I, HL-A8121J, HL-A8127L, HL-A8127M, HL-A8127N, HL-B1201A, HL-B1201B, HL-B1201C, HL-B1201D HL-A812P, HL-A812Q, HL-A812R, HL-A812S, HL-A813A, HL-A813B, HL-A813C, HL-A814A, HL-A814B, HL-A815A, HL-A815B, HL-A816A, HL-A8124P, HL-A8124Q, HL-A8124R, HL-A8124S, HL-A8124T, HL-A8124U, HL-A8124V, HL-A8124W, HL-A8124X, HL-A8124Y, HL-A8124Z, HL-A8125K, HL-A8125L, HL-A8125M, HL-A8125N, HL-A8125O, HL-A8126A, HL-A8126B, HL-A8126C, HL-A8126D, HL-A8126E, HL-A8126F, HL-A8124V, HL-A8125A, HL-A8125B, HL-A8125C, HL-A8125D, HL-A8125E, HL-A8125F, HL-A8125G, HL-A8125H, HL-A8125I, HL-A8125J, HL-A8114D, HL-A8114E, HL-A8114F, HL-A8114G, HL-A8114H, HL-A8114I, HL-A8114J, HL-A8114K, HL-A8114M, HL-A8115A, HL-A8115B, HL-A812D, HL-A812E, HL-A812G, HL-A812H, HL-A812I, HL-A812J, HL-A812K, HL-A812F, HL-A812L, HL-A812M, HL-A812N, HL-A812O, HL-A8127A, HL-A8127B, HL-A8127C, HL-A8127D, HL-A8127E, HL-A8127F, HL-A8127G, HL-A8127H, HL-A8127I, HL-A8127J, HL-A8127K, HL-A8115C, HL-A8115D, HL-A8115E, HL-A8116A, HL-A8117A, HL-A8117B, HL-A8117C, HL-A8117D, HL-A8117E, HL-A8117F, HL-A8117G, HL-A8118I, HL-A8119A, HL-A8119B, HL-A8119C, HL-A8119D, HL-A8119E, HL-A8119F, HL-A8120A, HL-A8120B, HL-A8120C, HL-A8120D, HL-A8121K, HL-A8121L, HL-A8121M, HL-A8121N, HL-A8121O, HL-A8121P, HL-A8121Q, HL-A8121R, HL-A8121S, HL-A8121T, HL-A8121U, HL-A811A, HL-A811B, HL-A811C, HL-A811D, HL-A811E, HL-A811F, HL-A811G, HL-A811H, HL-A811I, HL-A812A, HL-A812B, HL-A812C, HL-A8110D, HL-A8110E, HL-A8111A, HL-A8112A, HL-A8112B, HL-A8113A, HL-A8113B, HL-A8113C, HL-A8114A, HL-A8114B, HL-A8114C, HL-A8123C, HL-A8123D, HL-A8123E, HL-A8123F, HL-A8123G, HL-A8123H, HL-A8123I, HL-A8124A, HL-A8124B, HL-A8124C, HL-A8124D, HL-A817A, HL-A817B, HL-A817C, HL-A818A, HL-A818B, HL-A819A, HL-A819B, HL-A819C, HL-A8110A, HL-A8110B, HL-A8110C, Medical trolley,cabinet,table HL-D421A, HL-D421B, HL-D432A, HL-D432B, HL-D443A, HL-D443B, HL-D511A, HL-D511B, HL-D511C, HL-D611A, HL-D611B, HL-D611C Delivery Bed,Operating Table HL-A231A, HL-A231B, HL-A232A, HL-A232B, HL-A310A, HL-A310B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2020-03-03
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-03-03
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2020-03-03
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-03-03
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2020-03-03
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2025-12-04
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2025-12-04
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2020-03-03
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2020-03-03
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2020-03-03

Official Correspondent

Nancy Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HI-LIFE TECHNOLOGY (HEBEI) 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
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016590299. Last updated year: 2026. Please use registration number 3016590299 when referencing this establishment in official correspondence.