The Völkner® Turning System
14 catalogue numbers from BETA II Mattress Replacement, listed by James Consolidated, Inc., United States, under Mattress, Air Flotation, Alternating Pressure. 52 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (13), Fujian (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Xiamen Senyang Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| SHL Healthcare Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Xiamen HOY Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Apex Medical (Kunshan) Corp. | Kunshan | Jiangsu | Contract manufacturer | 4 |
| Shenzhen Fitconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 52. All 52 manufacturers in China registered for Mattress, Air Flotation, Alternating Pressure
Record
| Listed by | James Consolidated, Inc., United States |
|---|---|
| FDA product code | FNM |
| Device type | Mattress, Air Flotation, Alternating Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5550 |
| Premarket notification | Exempt |
| Record published | 2016-11-18 |
| Record revised | 2024-09-19 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BETA II Mattress Replacement | In distribution | |
| PANDA III 54″ Bariatric Mattress Replacement 84″ Special Production | In distribution | |
| MARK II Mattress Replacement 84″ Special Production | In distribution | |
| EUROPA I Mattress Overlay | In distribution | |
| MARK I Mattress Overlay 84″ Special Production | In distribution | |
| EUROPA I Mattress Overlay 84″ Special Production | In distribution | |
| MARK I Mattress Overlay | In distribution | |
| BETA II Mattress Replacement 84″ Special Production | In distribution | |
| BETA I Mattress Overlay | In distribution | |
| BETA I Mattress Overlay 84″ Special Production | In distribution | |
| PANDA III 54″ Bariatric Mattress Replacement | In distribution | |
| PANDA III 48″ Bariatric Mattress Replacement 84″ Special Production | In distribution | |
| PANDA III 48″ Bariatric Mattress Replacement | In distribution | |
| MARK II Mattress Replacement | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PressureGuard | Span-America Medical Systems, Inc. | 328 |
| Span-America | Span-America Medical Systems, Inc. | 286 |
| Medline | Medline Industries, Inc. | 228 |
| K-2oem ALT-Aire + | KAP Medical | 130 |
| SenTech | Tridien Medical | 129 |
| Mattress, Air Flotation, Alternating Pressure | Carilex Medical, Inc. | 118 |
| K-2 Kare-Zone | KAP Medical | 107 |
| K-4oem Aire-Float | KAP Medical | 90 |
| K-1oem ALT-Aire | KAP Medical | 72 |
| K-4 D³X | KAP Medical | 70 |
| Sizewise | Sizewise Rentals, L.L.C. | 68 |
| K-1 Derma-Kare | KAP Medical | 58 |
Showing 12 of 429. All products under Mattress, Air Flotation, Alternating Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K891457 | 1989-06-20 |
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.