Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004945434

FEI Number

3004945434

Entity Name

MBL POLAND SP. Z O.O.

City/State/Country

Piotrkow Trybunalski Lodzkie, PL

Establishment Address

ul. Sulejowska 45D, Piotrkow Trybunalski Lodzkie 97-300, PL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MBL Poland sp. z o.o. (Owner Number: 10057802)

Owner / Operator Contact Address

ul. Sulejowska 45 D, Piotrkow Trybunalski, PL-10 97-300, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PUSHRIM - D23 (+/-1 ) X 1 X 556/25"/6R-PD=534, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112822 ) TILT 50 deg (PM 4, P/N 20010101 Rev J) PUSHRIM - D23 X 1 X 398/18"/3R - PD=375, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112818 ) PUSHRIM - D23 X 1.25 X 537/24"/6R-PD=515, 8 KNOBS, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112825 ) TOP SHROUD; BY INJECTION MOULDED -BLACK ABS., (21514601-000 - REV B) SET OF ELECTRIC ACTUATOR NAQ002-C WITH MOUNTING PARTS (20010131) Pneumatic tyre OMOBIC SPEEDLITE 20'', black non-marking, etrto 25-451, IA2806 pattern PUSHRIM - D22 X 1 X 532 /24"/ 6 SPLICES SD=512 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA Pneumatic tyre OMOBIC TRAIBLAZER 20'', black non-marking, etrto 25-451, IA-2255 pattern PUSHRIM-D23 X 1.25 X 543/24"/6 SPLICES SD=523, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA) (112812 ) PUSHRIM - D23 (+/-1 ) X 1.25 X 499/22"/6R-PD=476, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112820 ) CASTOR WHEEL 7" SPARE SET ( 21508006 REV. B ) PUSHRIM-D23 X 1 X 532 /24"/6 SPLICES SD=512, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA) (112815) TYRE OMOBIC GAZELLE 24'', D23-540, BLACK NON MARKING, IA-2321 QUICK-RELEASE AXLE D1/2" X 104 MM, STAINLESS STEEL WITH BLACK TETRA HANDLE (ROUND TYPE) LIFT 160KG / 300MM /, LIMIT/INDI, (PM 8, P/N 20010305 REV F) SWL 215kg TETRA HANDLE FOR QR-AXLE, M12 X 1 X D20 X 24 MM, L - 59.5 MM, BLACK ANOD. ALUMINIUM (ROUND TYPE) S/A LEGREST FIXED, PA6-30%GF - RIGHT ( 22505215-002 REV.I ) FRONT FORK H 180 X W 53 MM, D 27 MM X 20 DG X T 9 MM, BLACK ANODIZED ALU.WITH d12.7 TOP HOLE AND 5 X d8.2 MM HOLES PUSHRIM - D23 (+/-1 ) X 1.25 X 537/24"/6R-PD=515, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112821 ) Pushrim 25", 531 mm fitting distance, aluminium with thin layer of black PVC paste, with 6 splices TYRE 26x1(25-590)-IA-2255, TRAILBLAZER,536(+/- 27G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING PUSHRIM - D19.6 X 1.25 X 506 MM/24"/6 BENT SPLICES-PD 523 MM,BLACK POWDER COATED ALU.WITH 9 SOFT ALU.KNOBS DAYLITE WHEEL - 24", BL DW ALU.RIM INCL.6 X M5 RVN.+?1/2"X48/70 BL ALU.RAD. HUB, 24 SUPER-LIGHT SPOKES/BL - RADIAL-R QUICK-RELEASE AXLE D12 X 122 MM, STAINLESS STEEL, WITH RED POWD.COAT.ALU. RELEASE BUTTON - FOR FLANGE HUB TILT & CAM LIFT 220KG / 300MM / 50DEG, INCHIBIT & SENSOR (SFE PM 10, P/N 20010250 rev G) TYRE 25x1(25-559)-IA-2255, TRAILBLAZER,510(+/- 26G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING,10 PCS/BOX PUSHRIM - D22 X 1 X 583 /26"/ 6 SPLICES SD=563 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA ELECTRIC ACTUATOR, 6000N, BID 263-267/100 MM, 24V, 2-PIN MOLEX 900MM, 270 DEGREE, W/O E-BRAKE; MOT136738 S/A LEGREST MANUAL - LEFT ( 22505214-001 Rev.E ) WITH GAS STRUT SM0876 PUSHRIM - D19.6 X 1.25 X 555 MM/26"/6 BENT SPLICES-PD 573 MM,BLACK POWDER COATED ALU.WITH 9 SOFT ALU.KNOBS WHEEL LOCK - LOCK-P - LEFT. 90 DEGREE VERSION, PLASTIC. (SPORT BRAKE)--WITH RADIUS AND RIBS Pneumatic tyre OMOBIC TRAIBLAZER 24'', black non-marking, etrto 25-540 IA-2255 pattern S/A LEGREST FIXED, PA6-30%GF - LEFT ( 22505215-001 REV.I ) Q300M BASE ( 21500650 - REV F ) - WITH PACKING FOR USA TYRE 26"x1"(25-590)-IA2806S,299(+/- 15G), SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING FOAM COVER d18 X D34 X 660 MM, BLACK ,FOR d20 MM TUBE (HARDNESS: 18-25SHC) TYRE 24" X 1 3/8", 37-540, INNOVA, BLACK, 1175#,BLOCK PATTERNED, 450KPA, IA-2803, 65PSI, 450kPa,NON-MARKING PUSHRIM-D23 X 1 X 582 /26"/6 SPLICES SD=564, ALU+THIN LAYER OF BLACK PVC PASTE (60-80 SHA) (112817) SET OF 95101DC2 WITH MOUNTING BOLTS (20010132) PUSHRIM-D23 X 1.25 X 498/22"/6R-PD=476, 8 KNOBS, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112824 ) WHEEL 8", D200 X 50 MM, D8 X 53 MM HUB, BLACK PLAST RIM 3 SPOKES WITH GREY TYRE/TUBE Pneumatic tyre OMOBIC SPEEDLITE 22'', black non-marking, etrto 25-501, IA2806 pattern DAYLITE WHEEL - 25", BL DW ALU.RIM INCL.6 X M5 RVN.+D1/2"X48/70 BL ALU.RADIAL HUB, 24 SUPER-LIGHT SPOKES/BL - RADIAL Pneumatic tyre OMOBIC SPEEDLITE 24'', black non-marking, etrto 25-540, IA2806 pattern TYRE 25x1"(25-559)-IA2806S,279(+/- 14G), SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING BAG WITH 500 CLIPS FOR FITTING OF SPOKE SHIELD MINI QUICK-RELEASE AXLE D10 X 35 MM, WITH WIRE AND 2 PCS RING, STAINLESS STEEL WHEEL 7", D175 X 45 MM, BLACK PLASTIC RIM, 3 SPOKES /D8 X 53 MM HUB, WITH GREY POLYURETHANE TYRE PUSHRIM - D22 X 1 X 552 /25"/ 6 SPLICES SD=532 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA Pneumatic tyre OMOBIC TRAIBLAZER 22'', black non-marking, etrto 25-501, IA-2255 pattern PUSHRIM - D22 X 1 X 492 /22"/ 6 SPLICES SD=472 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA PUSHRIM - D23 (+/-1 ) X 1.25 X 449/20"/6R-PD=426, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112819 ) WHEEL LOCK - LOCK-P - RIGHT. 90 DEGREE VERSION, PLASTIC, (SPORT BRAKE).--WITH RADIUS AND RIBS Pushrim OMOBIC NOVA H 24", 515 mm fitting distance, black hard anodized aluminium, with 6 splices S/A LEGREST MANUAL - RIGHT ( 22505214-002 Rev.E ) WITH GAS STRUT SM0876 PUSHRIM - D23 (+/-1 ) X 1.25 X 587/26"/6R-PD=565, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112823 )

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2018-05-29

Official Correspondent

Karolina Szubska

US Agent Details

Doug Barbacci Business: MBLNA LLC Email: doug@calexlogistics.com Phone: (570) 6023141

Related Public Records

Same Entity

MBL Poland sp. z o.o.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004945434. Last updated year: 2026. Please use registration number 3004945434 when referencing this establishment in official correspondence.