Identity
- Trade Name
- TR900 HI LO 110V US FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- TR900 HI LO 110V US FDA UDI
- Model / Reference
- 05192153 FDA UDI
- Description
- TR900 HI LO 110V US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350016061384 FDA UDI
- FDA Product Code
- KTC FDA UDI
- GMDN Term
- Hydrotherapy bath/tank FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5125 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hydrotherapy bath/tank
Tr900 Hi Lo 110v Us by Tr Equipment AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hydrotherapy bath/tank.
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- CRYSTAL ELECTRIQUE — France Reval · Class I
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- commode chair — Zhenjiang U-Nurse Medical Equipment Co.,Ltd · Class I
- Primo — Arjohuntleigh, Inc. · Class II
- Primo Ferro — Arjohuntleigh, Inc. · Class II
- Primo — Arjohuntleigh, Inc. · Class II
- Haltegriff Edelstahl, 40 cm — Ludwig Bertram GmbH · 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
- Tr Equipment AB
Sources (1)
- FDA UDI d066a0f9-85da-451d-aad1-a2389c6f850c 33 fields · synced May 30, 2026