FDA Registration
Active
🇨🇳 China
UPRISE ONYX KD SN RELEAS WLKR
Reg #: 3003781173
·
FEI: 3003781173
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD
- Registration Number
- 3003781173
- FEI Number
- 3003781173
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 4 and No 8 Plants 9 Shenghui South Road, Nantou Town
- City
- Zhongshan City Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Zhongshan A&E Machinery Industry Co., LTD
- Operator Number
- 10049449
- Address
- No 4 and No 8 Plants 9 Shenghui South Rd, Nantou Town
- City
- Zhongshan City
- State
- Guangdong
- Postal Code
- 510000
- Country
- CN
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2015-06-09 |
Proprietary Names
UPRISE ONYX KD SN RELEAS WLKR
GLIDE TIPS
UPRISE ONYX SIN RELEASE WALKER
WALKER FOLD DUAL REL ADLT
WALKER FOLD DUAL REL X-WD
STANDARD GLIDE BRAKES
3" SWIVEL WHEELS
WHEELS 5 SWVL FOR 1 WKRS
WHEELS 3 FXD FOR 1 WALKERS
WALKER DUAL REL X-WD W/5 WHEEL
WALKR FOLD DUAL REL X-WD W/WHL
WHEELS 5 FXD BARIATRIC WALKERS
WHEELS 5 FXD FOR 1 WALKERS
4" EXTENSION LEGS
WHEELS 5 AUTO-STOP 1 WKRS
WALKER W/5 WHLSDUAL REL 4/CS
WALKER FOLD SING REL ADLT
LUMEX DUAL RELEASE 1" JUNIOR
REPL LEG F/1" WALKERS & BATH
FXD WHEEL 5 W/ EXT 1 WLKRS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device