Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system FDA UDI
- Device Name
- The ManaCold Platinum Replacement Power Supply is a charging cord for the ManaCold Platinum cold water circulating device, normally sold with the original ManaCold Platinum. This is a replacement only for a lost cord. FDA UDI
- Model / Reference
- ManaCold Platinum Replacement Power Supply FDA UDI
- Description
- The ManaCold Platinum Replacement Power Supply is a charging cord for the ManaCold Platinum cold water circulating device, normally sold with the original ManaCold Platinum. This is a replacement only for a lost cord. FDA UDI
Identifiers
- Catalog Number
- MCOLDCHG FDA UDI
- Primary DI / UDI-DI
- 00810113682556 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-fluid localized thermal therapy system
ManaMed by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Circulating-fluid localized thermal therapy system.
- Welkins — Welkins, LLC · Class II
- Ebb Insomnia Therapy — CEREVE INC · Class II
- Brace Direct — BRACE ALIGN · Class II
- Brace Direct — BRACE ALIGN · Class II
- Kelvi — HYPOTHERMIA DEVICES, INC. · Class II
- Ebb Insomnia Therapy — CEREVE INC · Class II
- FORCE X — Xiamen Weiyou Intelligent Technology Co., Ltd · Class II
- Kelvi — HYPOTHERMIA DEVICES, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI f047c04a-a746-4e1c-9909-39f79fd7a53c 35 fields · synced Jun 8, 2026