PressureGuard
Alternating Pressure Mattress Control Unit
52manufacturers in China registered for this device type
328catalogue numbers in this listing
8510(k) clearances naming 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 | Span-America Medical Systems, Inc., United States |
|---|---|
| FDA product code | FNM |
| Device type | Mattress, Air Flotation, Alternating Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5550 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-31 |
| Record revised | 2025-07-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2025-07-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Custom Care Convertible | In distribution | |
| PG Protocol | In distribution | |
| Easy Air LR | In distribution | |
| Easy Air | In distribution | |
| Easy Air | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| APM II | In distribution | |
| Easy Air | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| APM | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| PG Protocol | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| Span Care Convertible | In distribution | |
| Easy Air | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Span Care | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Easy Air | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Easy Air | In distribution | |
| APM II | In distribution | |
| Span Care Convertible | In distribution | |
| APM II | In distribution | |
| Easy Air LR | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| PG Protocol | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| EASY AIR | In distribution | |
| Easy Air LR | In distribution | |
| Easy Air | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Protocol | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Custom Care LAL | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| MEM | In distribution | |
| APM II | In distribution | |
| Span Care | In distribution | |
| Span Care Convertible | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care | In distribution | |
| APM II | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| APM | In distribution | |
| Span Care | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| PG Protocol | In distribution | |
| CUSTOM CARE | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| PG Protocol | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Easy Air LR | In distribution | |
| APM II | In distribution | |
| Protocol | In distribution | |
| Custom Care Convertible | In distribution | |
| MEM | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Safety Supreme | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| PG Protocol | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| APM II | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Easy Air | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| MEM | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care | In distribution | |
| Custom Care Convertible | In distribution | |
| APM | In distribution | |
| Span Care Convertible | In distribution | |
| APM | In distribution | |
| PG Protocol | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Custom Care LAL | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| APM Bariatric | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| APM2 | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| APM II | In distribution | |
| Span Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Custom Care LAL | In distribution | |
| Span Care Convertible | In distribution | |
| PG Protocol | In distribution | |
| APM II | In distribution | |
| Safety Supreme | In distribution | |
| Span Care | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Custom Care Convertible | In distribution | |
| Span Care Convertible | In distribution | |
| Easy Air XL | In distribution | |
| APM | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| PG Protocol | In distribution | |
| APM II | In distribution | |
| Span Care | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| APM | In distribution | |
| Span Care Convertible | In distribution | |
| Easy Air LR | In distribution | |
| Custom Care Convertible | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| APM2 | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| APM | In distribution | |
| APM | In distribution | |
| Custom Care Convertible | In distribution | |
| PG Protocol | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| APM | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| Easy Air | In distribution | |
| APM II | In distribution | |
| APM II | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Protekt Aire | Proactive Medical Products | 54 |
Showing 12 of 429. All products under Mattress, Air Flotation, Alternating Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K973169 | 1998-02-20 |
| K960188 | 1996-10-02 |
| K961159 | 1996-06-14 |
| K960620 | 1996-04-25 |
| K954766 | 1996-01-11 |
| K953503 | 1995-10-24 |
| K951112 | 1995-06-06 |
| K932681 | 1993-11-12 |
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.