Handicare
Handicare - Carry Bar - Spring Latch - QRS - 550mm Length Assem
71manufacturers in China registered for this device type
166catalogue numbers in this listing
15recalls 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.
| 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
| Listed by | Handicare USA, Inc., United States |
|---|---|
| FDA product code | FSA |
| Device type | Lift, Patient, Non-Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5510 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-22 |
| Record revised | 2025-06-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Case of 10 |
| Distribution end date | 2024-02-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 323240 | In distribution | |
| 360982 | In distribution | |
| 360404M | In distribution | |
| 360406 | In distribution | |
| 360981 | In distribution | |
| 360760 | In distribution | |
| 400608A | In distribution | |
| 341520 | In distribution | |
| 323127 | In distribution | |
| 323246 | In distribution | |
| 323228 | In distribution | |
| 324206 | In distribution | |
| 280425 | In distribution | |
| 329150M | In distribution | |
| 323217M | In distribution | |
| 323244 | In distribution | |
| 341522 | In distribution | |
| 450005 | In distribution | |
| 323237V | In distribution | |
| 360935 | In distribution | |
| 450013 | In distribution | |
| 323177 | In distribution | |
| 323450 | In distribution | |
| 341506 | In distribution | |
| 329102 | In distribution | |
| 341500 | In distribution | |
| 400019 | In distribution | |
| 360986 | In distribution | |
| 360752 | In distribution | |
| 324205 | In distribution | |
| 323211 | In distribution | |
| 323251 | In distribution | |
| 324207 | In distribution | |
| 329154 | In distribution | |
| 323237 | In distribution | |
| 323126M | In distribution | |
| 323213 | In distribution | |
| 400607 | In distribution | |
| 370856 | In distribution | |
| 329180 | In distribution | |
| 323117V | In distribution | |
| 323626 | In distribution | |
| 370871 | In distribution | |
| 324200 | In distribution | |
| 341526 | In distribution | |
| 360985 | In distribution | |
| 341502 | In distribution | |
| 341503 | In distribution | |
| 370826 | In distribution | |
| 323117 | In distribution | |
| 329126 | In distribution | |
| 341515 | In distribution | |
| 360408 | In distribution | |
| 323245 | In distribution | |
| 370849 | In distribution | |
| 323240M | In distribution | |
| 323649 | In distribution | |
| 323257 | In distribution | |
| 323236 | In distribution | |
| 323118 | In distribution | |
| 341507 | In distribution | |
| 329192 | In distribution | |
| 450001 | In distribution | |
| 323237M | In distribution | |
| 450019 | In distribution | |
| 450003 | In distribution | |
| 341511 | In distribution | |
| 323241 | In distribution | |
| 323261 | In distribution | |
| 450006 | In distribution | |
| 329104 | In distribution | |
| 329150 | In distribution | |
| 323602 | In distribution | |
| 323101 | In distribution | |
| 341527 | In distribution | |
| 323120 | In distribution | |
| 341521 | In distribution | |
| 323427 | In distribution | |
| 323217 | In distribution | |
| 324204 | In distribution | |
| 450007 | In distribution | |
| 400603 | In distribution | |
| 323400 | In distribution | |
| 400006 | In distribution | |
| 329181 | In distribution | |
| 323242 | In distribution | |
| 323246M | In distribution | |
| 323223 | In distribution | |
| 323100 | In distribution | |
| 400000 | In distribution | |
| 341512 | In distribution | |
| 400013 | In distribution | |
| 360405M | In distribution | |
| 323150M | In distribution | |
| 329100 | In distribution | |
| 341505 | In distribution | |
| 324203 | In distribution | |
| 329137 | In distribution | |
| 323218 | In distribution | |
| 324223 | In distribution | |
| 323149 | In distribution | |
| 370840 | In distribution | |
| 323201 | In distribution | |
| 400003 | In distribution | |
| 329100M | In distribution | |
| 323601 | In distribution | |
| 323650 | In distribution | |
| 341516 | In distribution | |
| 400601 | In distribution | |
| 323127V | In distribution | |
| 450000 | In distribution | |
| 329187 | In distribution | |
| 280226 | In distribution | |
| 400007 | In distribution | |
| 329191 | In distribution | |
| 370800 | In distribution | |
| 323150 | In distribution | |
| 280400 | In distribution | |
| 323103 | In distribution | |
| 329151 | In distribution | |
| 280403 | In distribution | |
| 329190 | In distribution | |
| 450045 | In distribution | |
| 323236M | In distribution | |
| 323126Q | In distribution | |
| 400602 | In distribution | |
| 341517 | In distribution | |
| 400600 | In distribution | |
| 323150V | In distribution | |
| 360753 | In distribution | |
| 341400 | In distribution | |
| 323231 | In distribution | |
| 341510 | In distribution | |
| 329101 | In distribution | |
| 323119 | In distribution | |
| 323417 | In distribution | |
| 324201 | In distribution | |
| 323102 | In distribution | |
| 341525 | In distribution | |
| 323126 | In distribution | |
| 360744 | In distribution | |
| 323100V | In distribution | |
| 324202 | In distribution | |
| 323137 | In distribution | |
| 280402 | In distribution | |
| 329103 | In distribution | |
| 280401 | In distribution | |
| 360761 | In distribution | |
| 360931 | In distribution | |
| 329184 | In distribution | |
| 323215 | In distribution | |
| 360980 | In distribution | |
| 323600 | In distribution | |
| 547104 | In distribution | |
| 400001 | In distribution | |
| 329153 | In distribution | |
| 303093 | Withdrawn | |
| 303091 | Withdrawn | |
| 303060 | Withdrawn | |
| 303070 | Withdrawn | |
| 303073 | Withdrawn | |
| 303080 | Withdrawn | |
| 303077 | Withdrawn | |
| 303075 | Withdrawn | |
| 303090 | Withdrawn | |
| 303074 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZ Way | EZ WAY, Inc. | 371 |
| Handi-Move Sling | Handi-Move | 239 |
| Arjo Sling | Arjohuntleigh AB | 195 |
| 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 |
| Maxi Sky 2 | Arjohuntleigh AB | 50 |
Showing 12 of 311. All products under Lift, Patient, Non-Ac-Powered
Recalls
15 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-09-08 | Class II | Component design/selection | During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause a | 8 units | 2018-12-17 |
| 2017-01-30 | Class II | Device Design | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | 21 | 2017-12-04 |
| 2017-01-30 | Class II | Device Design | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | 76 | 2017-12-04 |
| 2016-08-30 | Class II | Device Design | The black plastic puck on the carry bar is breaking resulting in potential for patient harm. | not greater than 17,964 units | 2018-07-18 |
| 2015-09-08 | Class II | Device Design | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use | 1,721 lifts | 2017-05-04 |
| 2015-09-08 | Class II | Device Design | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use | 561 lifts | 2017-05-04 |
| 2015-06-24 | Class II | Other | There is a potential the sling loops may not stay attached to the carry bar hooks. | 7105 lifts | 2017-04-03 |
| 2015-06-24 | Class II | Other | There is a potential the sling loops may not stay attached to the carry bar hooks. | 409 lifts | 2017-04-03 |
| 2013-10-30 | Class II | Device Design | The lift might fail with the labeled 500-lb. load rating. | 233 units | 2017-05-17 |
| 2013-10-30 | Class II | Device Design | The lift might fail with the labeled 500-lb. load rating. | 97 units | 2017-05-17 |
| 2013-05-23 | Class II | Employee error | The product does not meet the firm’s size standards, the product was produced in the incorrect size. | 10 slings | 2013-11-25 |
| 2013-05-23 | Class II | Employee error | The product does not meet the firm’s size standards, the product was produced in the incorrect size. | 1 sling | 2013-11-25 |
| 2013-05-23 | Class II | Employee error | The product does not meet the firm’s size standards, the product was produced in the incorrect size. | 5 slings | 2013-11-25 |
| 2013-05-23 | Class II | Employee error | The product does not meet the firm’s size standards, the product was produced in the incorrect size. | 5 slings | 2013-11-25 |
| 2012-11-29 | Class II | Device Design | Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub. | 3301 handsets | 2014-12-08 |
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.