Sling, NB Toilet XL
Catalogue number GR122, listed by Invacare GmbH, Germany, under Lift, Patient, Non-Ac-Powered. 71 manufacturers in China are registered for this product 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 | Invacare GmbH, Germany |
|---|---|
| FDA product code | FSA |
| Device type | Lift, Patient, Non-Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5510 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-10 |
| Record revised | 2023-10-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date |
| Distribution end date | 2019-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GR122 | Withdrawn |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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K840997 | 1984-04-17 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2018-11-16 | Class II | Device Design | Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause wear to the hardware and housings. If left unresolve | 73,703 units | 2020-04-15 |
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.