Calypso

Calypso height-adjustable bath lift & hygiene chair, electric. w/scale

Registry build 21.09.26
71manufacturers in China registered for this device type
4catalogue numbers in this listing
5recalls on this code

Who Else Makes It

Concentrated in Guangdong (32), Jiangsu (15), Zhejiang (7). 26 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSA
Manufacturer City Province Registered as Device types
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Jiangyin Huashi Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 21
Hebei Jiede Medical Equipment Co., Ltd. Hengshui Hebei Contract manufacturer 20
Tops Medical Articles Industries Nantong Inc Qidong Jiangsu Contract manufacturer 17
Raise Medical Industries, Inc. Foshan Guangdong Contract manufacturer 16
Foshan Dongfang Medical Equipment Manufactory(Ltd) Foshan Guangdong Contract manufacturer 14
Genteel Homecare Products Co., Ltd. Foshan Guangdong Contract manufacturer 12
Dongguan Vigor Textile Co., Ltd. Dongguan Guangdong Contract manufacturer 11
Ningbo Kangmailong Medical Apparatus Co., Ltd. Cixi City, Ningbo Zhejiang Contract manufacturer 10
Ehob (Shanghai) Medical Products Co., Ltd. Pudong Shanghai Contract manufacturer 8
Jiangmen Jia Mei Medical Products Co., Ltd. Heshan Guangdong Contract manufacturer 8
Shanghai Ehob Health Care Products Co., Ltd. Shanghai Shanghai Contract manufacturer 8

Showing 12 of 71. All 71 manufacturers in China registered for Lift, Patient, Non-Ac-Powered

Record

Regulatory record for Calypso
Listed by Arjohuntleigh AB, Sweden
FDA product code FSA
Device type Lift, Patient, Non-Ac-Powered
Device class Class 1
Regulation 21 CFR 880.5510
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-07-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Calypso
Catalogue number Size Status
CDB7023-01 In distribution
CDB7003-01 In distribution
CDB6003-01 In distribution
CDB6023-01 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EZ Way EZ WAY, Inc. 371
Handi-Move Sling Handi-Move 239
Arjo Sling Arjohuntleigh AB 195
Handicare Handicare USA, Inc. 166
Slings Joerns Healthcare 155
M-Series Savaria Concord Lift 100
GoLift Amico Mobility Solutions 87
Medline Medline Industries, Inc. 81
M-Series Savaria Concord Lifts Inc. 64
Monarch Savaria Concord Lifts Inc. 62
Apex Lifts Joerns Healthcare 58
Drive Drive DeVilbiss Healthcare 57

Showing 12 of 311. All products under Lift, Patient, Non-Ac-Powered

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2009-08-18 Not classified Manufacturing material removal A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for po 214 units 2010-01-07
2009-06-11 Not classified Device Design Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position. 1,987 hygiene chairs 2010-08-19
2009-04-27 Not classified Equipment maintenance The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter. 8,015 lifts 2011-02-25
2009-02-26 Not classified Other If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver. 103,108 total slings 2011-02-25
2009-02-26 Not classified Other If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver. 103,108 total slings 2011-02-25

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer