Who else makes this device?

Name: Isolibrium
Brand: Isolibrium

Isolibrium · Bed, Patient Rotation, Powered → Physical Medicine

1manufacturer

4catalogue numbers in this listing

1recall

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code IKZ
Manufacturer	City	Province	Registered as	Device types
Ningbo Kangmailong Medical Apparatus Co., Ltd.	Cixi City, Ningbo	Zhejiang	Contract manufacturer	10

Record

Regulatory record for Isolibrium
Listed by	Stryker GmbH, Switzerland
FDA product code	IKZ
Device type	Bed, Patient Rotation, Powered
Device class	Class 2
Regulation	21 CFR 890.5225
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-24
Record revised	2020-01-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Storage	Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -40 to 140 °F; Handling environment temperature -40 to 140 °F; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal
Distribution end date	2019-12-20

Catalogue Numbers

Catalogue numbers for Isolibrium
Catalogue number	Size	Status
2972		In distribution
2971		In distribution
297300000000		In distribution
2972		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hill-Rom	Tridien Medical	88
K-Z Z-Turn	KAP Medical	59
K-6 Turn-Zone	KAP Medical	51
K-6oem Aire-Turn Assist	KAP Medical	43
K-Zoem EZ-Turn	KAP Medical	41
K-6oem Aire-Turn	KAP Medical	14
SenTech	Tridien Medical	9
K-6oemFAMS	KAP Medical	8
Airisana	Encompass Group, L.L.C.	7
The Freedom Bed	Probed Medical Technologies, Inc.	7
K-Z iTURN	KAP Medical	6
K-Z EZ-Turn	KAP Medical	4

Showing 12 of 22. All products under Bed, Patient Rotation, Powered

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Isolibrium
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stryker GmbH	UDI-DI	2021-05-12	Class II	Under Investigation by firm	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b	1 unit

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.

Isolibrium