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Qool-air

FDA UDI

Class II (US FDA UDI)

by Quanta System Spa

Identity

Trade Name
Qool-air FDA UDI
Generic Name
Localized cutaneous/musculoskeletal cryotherapy unit FDA UDI
Model / Reference
EAM000710 FDA UDI

Identifiers

Primary DI / UDI-DI
08033945936952 FDA UDI
510(k) Number
K171711 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Localized cutaneous/musculoskeletal cryotherapy unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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: Localized cutaneous/musculoskeletal cryotherapy unit

Qool-air by Quanta System Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Localized cutaneous/musculoskeletal cryotherapy unit.

Cleared under the same submission

K171711 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quanta System Spa

Sources (1)

  • FDA UDI eb2bcaaf-36f4-48da-a6e4-49b531720acd 33 fields · synced May 30, 2026