FDA Registration
Active
🇩🇪 Germany
THOMASHILFEN
Reg #: 9615019
·
FEI: 3003751850
·
Expires 2026
Products
4
Proprietary Names
85
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- THOMASHILFEN
- Registration Number
- 9615019
- FEI Number
- 3003751850
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- WALKMUEHLENSTRASSE 1
- City
- BREMERVOERDE Lower Saxony
- Country
- DE
Owner / Operator
- Firm Name
- THOMASHILFEN
- Operator Number
- 9034645
- Address
- WALKMUEHLENSTRASSE 1, --
- City
- BREMERVOERDE
- State
- Lower Saxony
- Postal Code
- 27432
- Country
- DE
- Correspondent
- Hans-Georg - Hoeft
US Agent
- Business Name
- EXOMOTION LLC. dba Thomashilfen
- Contact Name
- Darlene Hawthorne
- Address
- 14221 29th St E # 1
- City
- Sumner
- State
- WA
- ZIP
- 98390
- Country
- US
- [email protected]
- Phone
- 866 8702122
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2005-06-01 |
| Bath, Sitz, Nonpowered | KTC | Class 1 | Physical Medicine | No | 2021-05-19 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2005-06-01 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2005-06-01 |
Proprietary Names
Seat depth reducer
under seat storage basket
Seat width reducer
Chin support
Lateral trunk support, swing away
Drum brake kit
Rain cape, poncho
Crotch pad incl. magnetic lock
Pelvic belt
Hi/low indoor base
Arm rest
Crotch strap
Head pillow
Pneumatic wheels
Design package tRide
Headrest standard
Adapter Q-chassis
Sun/Rain cover
Straps - wrist "runaway" tether
Advantage chassis
Sleeping bag
Tip assist
Calf strap
canopy for legs
Vent tray
Chest Harness
Mouting hardware special headrest
Lateral head support
Headrest shell
Straps - secure folded seat/frame
Footrest tube upholstery
Hip belt
Rain shield
Medical necessity pack
Q-chassis
Rain canopy
Lateral trunk support
Push bar
Seat minimizer upholstery
Leg blanket
Head rest
front wheels
Impulse sensors, lateral
back wheels
Bus tie-downs
Cargo basket
Headrest adjustable winged
Frame padding
Soft pelvic harness
Belt bow
Footrest pad
Trunk pads
Foot strap
Side paddings
basket
Headrest neck support
Abduction block
Grab bar
Umbrella
Sun and rain canopy
Tray
EASyS adapter Q-chassis
Butterfly chest harness
Pelvis support
Z-chassis
Incontinence seat pad
5-point harness
under seat storage bag
Simplex bath chair
Swifty 3
ThevoTherapy
Swifty 2
EASyS Advantage
Swifty
EASyS Modular S
tRide
ThevoSiiS
ThevoTwist
ThevoRelief
ThevoFlex
ThevoSleepingStar
ThevoautoActiv
ThevoCalm
ThevoVital
ThevoRest
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility