FDA Registration
Active
🇺🇸 United States
Rolko rim tape 22x1.3/8
Reg #: 3016661582
·
FEI: 3016661582
·
Expires 2025
Products
1
Proprietary Names
33
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 |
|---|---|---|---|---|---|
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2020-03-31 |
Proprietary Names
Rolko rim tape 22x1.3/8
ball bearing 6002 2RS
Rolko grip extension 40 mm GV-19/40
Rolko tube cover, black, 680 mm long
Rolko hand grip, ergo, grey/black
Rolko rim tape
special ball bearing
Rolko rim tape 24x1.3/8
ball bearing 6201 2RS
ball bearing 1/2" 2RS
Rolko Umbrella rod mount
Rolko rim tape from polyurethane 24x1
Rolko tube cover, black, 210 mm long
Rolko round tube clamps
Rolko Hand grip, anatomical (PAIR, left and right side)
Rolko Support system for half-size therapy table
Rolko hand grip, soft foam rubber, black
Rolko tube cover, black, 680 mm long, smooth surface
Rolko tube cover, black, 210 mm long, smooth surface
Rolko hand grip, plastic, black
Ball bearing type 6900 2RS
Rolko hand grips, plastic, black
ball bearing 6001 2RS
Rolko Support system for therapy table
ball bearing 608 2RS
Rolko hand grips, plastic, black GR-KS
Rolko ball bearing 1/2" R8 - 2RS
Rolko grip extension 70 mm GV-22/70
Rolko grip extension 70 mm GV-19/70
Rolko tube cover, black, 260 mm long, smooth surface
Rolko grip extension 40 mm GV-22/40
ball bearing type 6000 2RS
Rolko hand grips, plastic, black GR-KS-RE
Establishment Types
Repack or Relabel Medical Device