Waffle
1056ECP Waffle Econo Extended Care Plus Mattress PAD W/PMP - Sngl
30manufacturers in China registered for this device type
22catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (8), Zhejiang (4). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Ehob (Shanghai) Medical Products Co., Ltd. | Pudong | Shanghai | Contract manufacturer | 8 |
| Shanghai Ehob Health Care Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Xiamen Senyang Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| EHOB(JiaXing) Medical Product Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 7 |
| SHL Healthcare Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| JHQ NEW Material Technology Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 3 |
| Shanghai Shenbao Mattress Factory | Shanghai | Shanghai | Contract manufacturer | 2 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
Showing 12 of 30. All 30 manufacturers in China registered for Mattress, Flotation Therapy, Non-Powered
Record
| Listed by | Ehob, Inc., United States |
|---|---|
| FDA product code | IKY |
| Device type | Mattress, Flotation Therapy, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Box of 6, box of 12, box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution | |
| REV00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Span-America | Span-America Medical Systems, Inc. | 720 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 431 |
| Cmatt | Casco Manufacturing Solutions, Inc. | 62 |
| Drivemedical | Drive DeVilbiss Healthcare | 40 |
| Drive | Drive DeVilbiss Healthcare | 39 |
| Lounge Doctor | Legs 4 Life, LLC | 28 |
| PrevaMatt | Joerns Healthcare | 28 |
| Accumax Surface | Hill-ROM, Inc. | 26 |
| NP50 Surface | Hill-ROM, Inc. | 23 |
| GeoMattress | Span-America Medical Systems, Inc. | 19 |
| NP100 Surface | Hill-ROM, Inc. | 19 |
| Immersus | Immersus Health Company, LLC | 18 |
Showing 12 of 417. All products under Mattress, Flotation Therapy, Non-Powered
Recalls
2 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 |
|---|---|---|---|---|---|
| 2021-04-19 | Class II | Process control | Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates | 70 units | |
| 2020-01-19 | Class II | Material/Component Contamination | Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potent | U.S. (TX) | 2020-08-05 |
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.