Identity
- Trade Name
- PARATherm FDA UDI
- Generic Name
- Physical therapy paraffin wax bath FDA UDI
- Device Name
- bath, paraffin FDA UDI
- Model / Reference
- PARATherm FDA UDI
- Description
- bath, paraffin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861047000329 FDA UDI
- 510(k) Number
- K842423 FDA UDI
- FDA Product Code
- IMC FDA UDI
- GMDN Term
- Physical therapy paraffin wax bath FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5110 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy paraffin wax bath
PARATherm by Grimm Scientific Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy paraffin wax bath.
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- Therabath — WR Medical Electronics Co. · Class II
- Dickson Paraffin Bath — Whitehall Manufacturing Co · Class II
- Therabath — WR Medical Electronics Co. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Grimm Scientific Industries, Inc.
Sources (1)
- FDA UDI 19fcec57-910b-426b-8eee-231da564bc07 35 fields · synced May 30, 2026