Identity
- Trade Name
- RL-500 FDA UDI
- Generic Name
- Hand/wrist continuous passive motion exerciser FDA UDI
- Device Name
- Hose 1ea, Com cable 1ea (1 set box) FDA UDI
- Model / Reference
- 1000860 FDA UDI
- Description
- Hose 1ea, Com cable 1ea (1 set box) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315679817 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Hand/wrist continuous passive motion exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand/wrist continuous passive motion exerciser
Rl-500 by Daesung Maref Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand/wrist continuous passive motion exerciser.
- rebless — H ROBOTICS INC. · Class I
- rebless — H ROBOTICS INC. · Class I
- rebless — H ROBOTICS INC. · Class I
- rebless — H ROBOTICS INC. · Class I
- rebless — H ROBOTICS INC. · Class I
- rebless — H ROBOTICS INC. · Class I
- Vector 1 — Lantz Medical · Class I
- rebless — H ROBOTICS INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
Sources (1)
- FDA UDI 7f8006fb-8d93-46aa-a1cd-be113f140fe7 33 fields · synced May 30, 2026