Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003781173

FEI Number

3003781173

Entity Name

ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

No 4 and No 8 Plants 9 Shenghui South Road, Nantou Town, Zhongshan City Guangdong 510000, CN

Establishment Type(s)

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

Owner / Operator

Zhongshan A&E Machinery Industry Co., LTD (Owner Number: 10049449)

Owner / Operator Contact Address

No 4 and No 8 Plants 9 Shenghui South Rd, Nantou Town, Zhongshan City, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NEB-U-TYKE TRAIN DISPLAY RESERVOIR TUBE FOR NEB SPEEDST ACCESSORY KIT (PEN,STAR,HEART) NEB-U-TYKE RR TRAIN FILTER CAPS NEB-U-TYKE TRAIN FILTER CAPS FOR EV NEB FILTER FOR NEB PENGUIN & EV NEB-U-TYKE SPEEDSTER REPL FILTER FOR NEB-A-DOODLE NEB-U-TYKE NEB-A-DOODLE NEB-U-TYKE IC - PENGUIN RPLCMT BUMPER NEB-U-TYKE TRAIN FILTER PACK FOR NEB SPEEDSTER NEBULIZER CUP EACH FILTER PK FOR NEB-U-TYKE TRAIN CABINET FILTER FOR OPTIUM NEB-U-TYKE RACETRACK DISPLAY FILTER CAP FOR NEB-A-DOODLE DRAWING BRD FOR NEB-A-DOODLE NEB-U-TYKE IGLOO DISPLAY NEB-U-LITE EV 12/CS DUKAL Electric Perfect Leg Stretcher RAIL CROSSBRACE KNOBS 6/CS LIBERTY CROSSBARS (BEIGE) CROSSBAR BED UNIVERSAL CHROME BED RAILS FULL TELE UNIV CHRM REPLACEMENT CROSSBRACE SLEEVES BED RAILS LBTY QUARTER RAIL HI REPLC KNOB FOR GF6650A-1 RAILS STANDARD GLIDE BRAKES WHEELS 5 FXD BARIATRIC WALKERS WHEELS 5 AUTO-STOP 1 WKRS WALKR FOLD DUAL REL X-WD W/WHL UPRISE ONYX SIN RELEASE WALKER WHEELS 5 FXD FOR 1 WALKERS WALKER DUAL REL X-WD W/5 WHEEL 4" EXTENSION LEGS LUMEX DUAL RELEASE 1" JUNIOR GLIDE TIPS FXD WHEEL 5 W/ EXT 1 WLKRS UPRISE ONYX KD SN RELEAS WLKR WALKER FOLD SING REL ADLT WHEELS 3 FXD FOR 1 WALKERS WALKER W/5 WHLSDUAL REL 4/CS 3" SWIVEL WHEELS WALKER FOLD DUAL REL ADLT WHEELS 5 SWVL FOR 1 WKRS WALKER FOLD DUAL REL X-WD REPL LEG F/1" WALKERS & BATH Bariatric bed SUCTION RUBBER FEET FOR 800 EV NUT FLTR FOR VACUTEC 800 EV2 REPLACEMENT BOTTLE HOLDER EV2 SUCTION TUBE FOR 800 EV2 COLLECTION BOTTLE FOR 800 EV2 FILTERS FOR VACUTEC 800 EV2 REPLACMENT HANDLE FOR 800 EV2 ASPIRATOR VACUTEC 800 EV2 CONNECTION TUBING FOR 800 EV2 REGULATOR ASSEMBLY FOR 800 EV2 ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD. INSTRUMENT TABLE MAYO TYPE TRACTION SET OVERDOOR TRACTION VYL WTR WT BAG 20 LB. HEAD HALTER UNIVERSAL BACK UPH,BLK NYLON 30W-PMT XD ARMS,DETACH DSK - PMT XD ANTI-TIPPER PR, PARAMOUNT XD BACK UPH,BLK NYLON 26W-PMT XD ARM PAD, DSK - PMT XD MEDICHOICE BARI WC 26W DSK SWF WHL LOCK,PUSH TO LOCK-PMT XD LEGREST, COMPLETE - PMT XD GRIP(10EACH) PMT XD AXLE,NUT&WASHER(10EA) PMT XD ANTI-FOLDING BAR, CHROMED (LOWER FRAME) MEDICHOICE BARI WC 30W DSK ELR SEAT UPH,BLK NYLN 30X18-PMT XD WHL LOCK EXTENSION - PMT XD W/C PARAMOUNT XD 26W DSK ELR MEDICHOICE BARI WC 30W DSK SWF REAR WHL, 24" - PMT XD SEAT UPH,BLK NYLN 26X18-PMT XD W/C PARAMOUNT XD 26W DSK SWF FOOTREST, COMPLETE - PMT XD ELR BLACK PANEL - PMT XD MEDICHOICE BARI WC 26W DSK ELR POSITIONING BELT - PMT XD W/C PARAMOUNT XD 30W DSK SWF W/C PARAMOUNT XD 30W DSK ELR RPL KNOBS PLASTIC-PMT XD CSTR OVERBED TBLE GF8905-1A OVERBED TABLE TLT-TOP DLX REPLACEMENT FABRIC XFER CHAIR MOUNTING PLATE ASSEMBLY FT STOOL ECN BLK EPXY FIN 2/CS TOILET SAFETY RAILS VERSAFRAME REPL LOCKING CASTERS-MC000480 STOOL SAFETY STEP W/LONG HNDL VERSAFRAME TOILET SAFETY 5ESC20 ECONOMY SHWR CHR FTRST BATH MAT SURE-SAFE WHITE REPLACEMENT TIP HAMPER FOLDING ADJUSTABLE SHOWER CHAIR ALUM 5 CASTERS REPL CASTERS 7910A-1, 7915A-1 REPL NON-LOCK CASTERS-MC000480 SPREADER BAR 12" REPL SEAT SHOWER TRANSP CHAIR REPLACEMENT SEAT FOR MC000480 SHOWER CHAIR ALUM W/FT RST 5ESC20 ECONOMY SHOWER CHAIR TRANS BENCH HVY DUTY TRANS BENCH HVY DUTY 1EA EXTEN LEGS 4" FOR 7927/7929 SUCTION CUPS LEGS CANVAS 1-PIECE SLING CSTRS FOR IV POLEGF7012-1 CANVAS 1-PIECE SLING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-08-31
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2018-03-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-07-10
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-07-10
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2015-06-09
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-06-09
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2016-06-14
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2015-07-10
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2020-08-31
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-01-11
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2015-07-10
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2015-07-10
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2015-07-10
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2020-08-31
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2015-06-09
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2015-06-09
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-07-10
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-07-10
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2020-08-31
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2015-07-10
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-06-02
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2015-07-10
IPR	Crutch	Physical Medicine	Class 1	890.3150	2020-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Zhongshan A&E Machinery Industry 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003781173. Last updated year: 2026. Please use registration number 3003781173 when referencing this establishment in official correspondence.