Invacare® Thinksoft® Positioning Device
2 catalogue numbers from IHRAILTS-DLX, listed by Invacare GmbH, Germany, under Bed, Ac-Powered Adjustable Hospital. 95 manufacturers in China are registered for this product code.
95manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (32), Jiangsu (20), Hebei (11). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Genteel Homecare Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 12 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Jiaxing Kalanchoe Medical Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 8 |
| Jiangmen Jia Mei Medical Products Co., Ltd. | Heshan | Guangdong | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Nantong Shunlong Physical Therapy Equipment Co., Ltd. | Rugao | Jiangsu | Contract manufacturer | 6 |
| Chengdu LI REN Electric Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 3 |
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 95. All 95 manufacturers in China registered for Bed, Ac-Powered Adjustable Hospital
Record
| Listed by | Invacare GmbH, Germany |
|---|---|
| FDA product code | FNL |
| Device type | Bed, Ac-Powered Adjustable Hospital |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-10-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2016-09-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IHRAILTS-DLX | In distribution | |
| IHCSTSPD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drive | Drive DeVilbiss Healthcare | 190 |
| Electrical Hospital Bed | Paramount BED Co., Ltd. | 164 |
| MC Healthcare | Span-America Medical Systems, Inc. | 160 |
| NOA Medical Industries, Inc. | Hoffmann NOA Medical Industries, LLC | 99 |
| Posey | Posey Products, LLC | 95 |
| Drivemedical | Drive DeVilbiss Healthcare | 94 |
| Enterprise | Arjohuntleigh AB | 80 |
| silverfox | Silverfox Corporation Limited | 77 |
| Electrical Hospital Bed with Digital Scale | Paramount BED Co., Ltd. | 70 |
| Basic American Medical Products | GF Health Products, Inc | 66 |
| Bed, Ac-Powered Adjustable Hospital | Gendron, Inc. | 50 |
| Accessories | Joerns Healthcare | 43 |
Showing 12 of 1,249. All products under Bed, Ac-Powered Adjustable Hospital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974296 | 1998-01-06 |
| K900151 | 1990-06-18 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2016-03-15 | Class II | Nonconforming Material/Component | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | 2,184 units | 2017-09-15 |
| 2016-03-15 | Class II | Nonconforming Material/Component | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | 2,702 units | 2017-09-15 |
| 2016-03-15 | Class II | Nonconforming Material/Component | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | 3,050 units | 2017-09-15 |
| 2016-03-15 | Class II | Nonconforming Material/Component | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | 1,011 units | 2017-09-15 |
| 2014-12-05 | Class II | Nonconforming Material/Component | Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety. | 2499 units | 2015-06-18 |
| 2006-10-16 | Not classified | Nonconforming Material/Component | Invacare Corporation, Florida issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890 IVC and 5490 IVC. The actuators were not in the fully extended position and could not be mounted | 731 | 2010-09-13 |
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.