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Pscs

FDA UDI

Class II (US FDA UDI)

by Paxman Coolers Limited

Identity

Trade Name
PSCS FDA UDI
Generic Name
Scalp cooling system, hair loss FDA UDI
Device Name
The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices. The unit circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head. The circulation of the refrigerated coolant through the cap extracts heat from the patient’s scalp and maintains it at the optimum temperature for scalp cooling. There are two versions of the device. One is for single patient use, PSCS1, the other is for two patient use, PSCS2. FDA UDI
Model / Reference
2 FDA UDI
Description
The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices. The unit circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head. The circulation of the refrigerated coolant through the cap extracts heat from the patient’s scalp and maintains it at the optimum temperature for scalp cooling. There are two versions of the device. One is for single patient use, PSCS1, the other is for two patient use, PSCS2. FDA UDI

Identifiers

Catalog Number
PSCS2 110V-PFU FDA UDI
Primary DI / UDI-DI
B561PSCS2115VPFU0 FDA UDI
510(k) Number
K163484 FDA UDI
K173032 FDA UDI
FDA Product Code
PMC FDA UDI
GMDN Term
Scalp cooling system, hair loss FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4360 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Scalp cooling system, hair loss

Pscs by Paxman Coolers Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scalp cooling system, hair loss.

Cleared under the same submission

K163484 also covers:

K173032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paxman Coolers Limited

Sources (1)

  • FDA UDI f8d21793-0330-4c89-a029-b481ca1fe907 36 fields · synced Jun 8, 2026