Who else makes this device?

Name: Coolief* Basic Generator
Brand: Coolief* Basic Generator

Neurology › SurgicalGenerator, Lesion, Radiofrequency

Coolief* Basic Generator

Catalogue number CRG-BASIC, listed by Avanos Medical, Inc., United States, under Generator, Lesion, Radiofrequency. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GXD
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
Cathay Manufacturing Corp.	Shanghai	Shanghai	Contract manufacturer	5

Record

Regulatory record for Coolief* Basic Generator
Listed by	Avanos Medical, Inc., United States
FDA product code	GXD
Device type	Generator, Lesion, Radiofrequency
Device class	Class 2
Regulation	21 CFR 882.4400
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K192491
Record published	2020-10-16
Record revised	2023-06-22 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Coolief* Basic Generator
Catalogue number	Size	Status
CRG-BASIC		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Generator, Lesion, Radiofrequency	Boston Scientific Neuromodulation Corporation	68
Generator, Lesion, Radiofrequency	Stryker Leibinger Gmbh & Co. KG	58
OneRF Ablation System	Neuroone Medical Technologies Corp.	7
GX1™	Boston Scientific Neuromodulation Corporation	7
Accurian	Medtronic Sofamor Danek, Inc.	7
Multigen 2	Stryker GmbH	6
Avanos*	Avanos Medical, Inc.	4
OWL	Diros Technology, Inc.	4
NeuroTherm™	Neurotherm, Inc.	3
Halyard	Avanos Medical, Inc.	3
Venom Multigen 2	Stryker GmbH	2
Relievant	Relievant Medsystems	2

Showing 12 of 26. All products under Generator, Lesion, Radiofrequency

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242057	2024-08-14
K192491	2020-02-21

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Coolief* Basic Generator
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Avanos Medical, Inc.	510(k) number	2023-08-01	Class II	Process change control	Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.	24 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.