FDA Registration Active 🇺🇸 United States

Rolko FIXATION CLAMP KL-STH-CL28

Reg #: 3016661582 · FEI: 3016661582 · Expires 2025
Products
1
Proprietary Names
121
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Rolko North America, Inc.
Registration Number
3016661582
FEI Number
3016661582
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
398 West 230th Street
City
Bloomfield
State
IA
ZIP
52537
Country
US

Owner / Operator

Firm Name
Rolko North America, Inc.
Operator Number
10065034
Address
808 Karr Ave, Suite B
City
Bloomfield
State
IA
Postal Code
52537
Country
US
Correspondent
Jill C Brown

Products

Device Name Product Code
Accessories, Wheelchair KNO

Proprietary Names

Rolko FIXATION CLAMP KL-STH-CL28 Rolko Body Warmer Rolko-Thermo, size M up to 168 cm Rolko 26X1.3/8 TUBE Rolko tire 24X1.3/8 R-103 TREAD SUPER LIGHT IMPAC 37-540 gray Rolko Fastening kit for push rim Rolko Polyurethane tyre 22 x 1.3/8", ETRTO 37-489 PU-R570/35-G-R402 Rolko 5" CASTER WHEEL-BLACK PLASTIC-1.8"W HUB 1.4" TREAD Rolko tire 22X1.3/8 R-124 TREAD 37-501 gray Schwalbe tire 26x1 RightRun 25-590 black Rolko polyurethane tire 20 x 1", ETRTO 25-451 PU-R510/25-G-R401-16 Rolko tire 24X1.3/8 R-121 TREAD 37-540 gray Rolko 6" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.4"W HUB-1.3" TREAD Rolko 7" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.7"W HUB-1.4" TREAD Schwalbe tire 24x2.15 Big Ben 55-507 black/reflective Rolko Polyurethane tyre 22 x 1.3/8", ETRTO 37-489 PU-R570/35-G-R401-21 Rolko Body Warmer Rolko-Thermo, size XXL up to 195cm Rolko spoke wheel "Active" with double wall aluminium rim, black, black pushrim, Schwalbe Right Run Rolko HINGES- JUNIOR 140MM HA-SP-ALU-J-140R Rolko Backstrap for rollators, black Rolko wheel with 3 hollow spokes plastic rim black, PU(3) black Schwalbe tire 24x1 Marathon Plus Evolution 25-540 black Rolko cane butler, black Rolko tube ETRTO 20-559 Schwalbe tire 24x1 Marathon Plus 25-540 grey/blackskin Schwalbe tire 24x1 RightRun 25-540 red/black Rolko 7" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-2.4"W HUB-1.4" TREAD Rolko IV CLAMPING ROD W/TILT Rolko FIXATION CLAMP KL-STH-CL25 Schwalbe tire 24x1 RightRun 25-540 blue/black Rolko 4" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.4"W HUB-1.2" TREAD ROLKO THERMO XS ROLKO THERMO XXS Rolko HINGES- 140MM HA-SP-ALU-100L Rolko HINGES- 140MM HA-SP-ALU-100R Rolko 5" CASTER WHEEL- BLACK PLASTIC-1.8"W HUB 1.6" TREAD Rolko heel strap 240-430mm, black Rolko 20X1.3/8 TUBE Rolko tire 24X1.3/8 R-105 TREAD 37-540 gray Rolko spoke wheel "Active" with double wall aluminium rim, black, black pushrim, PU tire Rolko 8" CASTER WHEEL-BLACK PLASTIC-2"W HUB 2.4" TREAD Rolko tube 24x1, car valve Rolko tire 24X1.3/8 R-121 PUNCTURE PROTECTION 37-540 gray Rolko leg rest moulding Rolko FIXATION CLAMP KL-STH-CL22 Rolko 4" CASTER WHEEL-BLACK PLASTIC-1.8"W HUB 1.4" TREAD Rolko 5" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.7"W HUB-1.2" TREAD Rolko IV POLE-CLAMP ONLY (MT-IN-R22) Rolko HINGES- 100MM HA-SP-ALU-100R Rolko tire 26x1 3/8 iMPAC R-119 TREAD 37-590 gray Rolko 5" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.4"W HUB-1.2" TREAD Rolko tire 24x1, grey, high pressure 25-540 gray/black Rolko 4" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.7"W HUB-1.2" TREAD Rolko Abduction block out of PU-foam, black PU-AK-M Rolko HINGES- JUNIOR 140MM HA-SP-ALU-J-140L Rolko ADDITIONAL SUPPORT PLATE- 37.5MM REACH Rolko IV POLE CLAMP ONLY (MT-IN-V22/25) Rolko 5" CASTER WHEEL-BLACK PLASTIC-2.4"W HUB 1.6" TREAD Rolko Polyurethane tyre 24 x 1", ETRTO 25-540 PU-R620/25-S-R401-16 Rolko 7" CASTER WHEEL-BLACK PLASTIC-1.8"W HUB 1.8" TREAD Rolko HINGES- JUNIOR 100MM HA-SP-ALU-J-100L Rolko heel strap 450mm, black Rolko HINGES- 100MM HA-SP-ALU-100L Rolko Abduction block out of PU-foam, black PU-AK-S Rolko Polyurethane tyre 24 x 1.3/8, ETRTO 37-540 PU-R620/35-G-R410-01 Rolko 6" CASTER WHEEL-LIGHT BLACK HOLLOW LOW PRO TREAD-1.7"W HUB-1.3" TREAD Rolko universal-mirror for Scooter Rolko Body Warmer Rolko-Thermo, size S (Junior) up to 158cm Rolko Transfer board Rolko wheel with aluminium rim spoked wheel "START", silver, black pushrim, grey tire Rolko Polyurethane tyre PROSPEED 24 x 1", ETRTO: 25-540 BLACK Rolko wheel 24" with alu rim, spoked, silver anodized Rolko Leg protection for wheelchair users Rolko-Thermo Rolko calf rest 150 x 125 mm Rolko wheel with aluminium double wall rim, black w/ black tab pushrim, PU tire Rolko calf rest 220 x 155 mm PU- foam, black Rolko 5.5" CASTER WHEEL-BLACK PLASTIC-1.8" W HUB 1.6" TREAD Rolko WHEEL LOCK CLAMP- 22mm/ 7/8" Rolko 5" CASTER WHEEL-BLACK PLASTIC-1.4"W HUB 1.4" TREAD Rolko HINGES- JUNIOR 100MM HA-SP-ALU-J-100R Schwalbe tire 24x1.3/8" DOWNTOWN 37-540 gray/black Rolko 22X1.3/8 TUBE Schwalbe tire 26 x 7/8 RightRun 23-559 gray/black Rolko polyurethane tire 20 x 1", ETRTO 25-451 PU-R510/25-G-R401-21 Rolko ABDUCTOR MOUNT 160MM LENGTH Rolko 7" CASTER WHEEL-BLACK PLASTIC-1.8"W HUB 2.4" TREAD Rolko Polyurethane tyre 24 x 1.3/8, ETRTO 37-540 PU-R620/35-S-R410-01 Schwalbe tire 24x1Marathon Plus Evo REFLEX 25-540 black/reflective Rolko Rolko-dribo: Water bottle with holder Rolko Abduction block out of PU-foam, black PU-AK-L Schwalbe tire 24x1 RightRun, 25-540 black/black Rolko IV CLAMPING ROD Rolko wheel 26" "BASIC" with alu rim, spoked, black, black pushrim, grey pneumo tire Rolko Wheel with light-weight double wall rim, black w/ black tab pushrim Schwalbe Right Run Rolko Easy Push Handle SGE-2 Rolko 4" CASTER WHEEL-BLACK PLASTIC-1.4"W HUB 1.4" TREAD Rolko wheel with 3-spokes plastic rim, black Schwalbe tire 24x1 DOWNTOWN 25-540 gray/black Rolko tire 22X1.3/8 R-119 TREAD 37-489 gray Schwalbe tire 26x1 Marathon Plus Evolution 25-559 black Rolko Polyurethane tyre 24 x 1", ETRTO 25-540 PU-R620/25-S-R401-20 Rolko FIXATION CLAMP KL-STH-22 Rolko tube 24x1" Rolko 24X1.3/8 TUBE Rolko 6" CASTER WHEEL-BLACK PLASTIC-1.4"W HUB 1.3" TREAD Schwalbe tire 26x1 Marathon Plus Evolution 25-590 black Rolko Polyurethane tyre 24 x 1.3/8, ETRTO 37-540 PU-R620/35-G-R401 Rolko tire 20X1.3/8 R-120 TREAD 37-451 gray Rolko Easy Push Handle SGE-3 Rolko 6" CASTER WHEEL-BLACK PLASTIC-1.8"W HUB 1.3" TREAD Rolko 360 DEG TURNTABLE SWIVEL ARM WITH SUPPORT PLATE 17.5MM REACH Rolko Body Warmer Rolko-Thermo, size L up to 178cm Rolko cane holder for 2 canes Rolko 5.5" CASTER WHEEL-BLACK PLASTIC-2.4" W HUB 1.6" TREAD Rolko wheel with plastic rim, black Rolko support with clamp for drink bottle Rolko wheel with 3 hollow spokes plastic rim, black Rolko ABDUCTOR MOUNT 80MM LENGTH Rolko FIXATION CLAMP KL-STH-25 Rolko tube 26 x 1" - car valve Rolko Fixation Belt 68 x 5 cm Rolko WHEEL LOCK CLAMP- 25mm/ 1"

Establishment Types

Repack or Relabel Medical Device