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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2020-03-31 |
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