Span-America
PG Easy AIR LR 80X39X7 Mattress W/ CLT-L8042 AND Bolster
52manufacturers in China registered for this device type
286catalogue 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 | 2022-07-05 |
| Record revised | 2025-07-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-09-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| The Topper | In distribution | |
| EASY AIR | In distribution | |
| PressureGaurd Span Care | In distribution | |
| CUSTOM CARE | In distribution | |
| PressureGuard Span Care Convertible | In distribution | |
| PressureGaurd Span Care | In distribution | |
| CUSTOM CARE NP | In distribution | |
| CUSTOM CARE | In distribution | |
| APM/ APM II | In distribution | |
| APM II | In distribution | |
| The Topper | In distribution | |
| APM/ APM II | In distribution | |
| EASY AIR XL | In distribution | |
| SPAN-CARE | In distribution | |
| EASY AIR LR CONTROL UNIT | In distribution | |
| PressureGaurd Span-Care | In distribution | |
| EASY AIR | In distribution | |
| The Topper | In distribution | |
| PressureGuard Custom Care LAL | In distribution | |
| PressureGuard | In distribution | |
| APM/ APM II | In distribution | |
| CUSTOM CARE | In distribution | |
| EASY AIR LR | In distribution | |
| APM | In distribution | |
| APM/ APM II | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGaurd Custom Care NP | In distribution | |
| Span Care Convertible | In distribution | |
| PressureGaurd Custom Care NP | In distribution | |
| CUSTOM CARE | In distribution | |
| SPAN-CARE | In distribution | |
| Custom Care Convertible | In distribution | |
| Geomattress | In distribution | |
| The Topper | In distribution | |
| HERCULES | In distribution | |
| EASY AIR LR | In distribution | |
| PressureGuard MEM | In distribution | |
| PROTOCOL | In distribution | |
| CUSTOM CARE CONVERTIBLE LAL | In distribution | |
| PressureGuard APM2 | In distribution | |
| CUSTOM CARE | In distribution | |
| APM/ APM II | In distribution | |
| EASY AIR LR | In distribution | |
| CUSTOM CARE NP | In distribution | |
| PressureGuard APM2 | In distribution | |
| OSKA APM2 | In distribution | |
| The Topper | In distribution | |
| EASY AIR LR | In distribution | |
| Topper | In distribution | |
| Span Care Convertible | In distribution | |
| Custom Care Convertible | In distribution | |
| PressureGuard Span Care Convertible | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| EASY AIR LR | In distribution | |
| EASY AIR | In distribution | |
| APM/ APM II | In distribution | |
| CUSTOM CARE | In distribution | |
| APM/ APM II | In distribution | |
| EASY AIR XL | In distribution | |
| EASY AIR XL | In distribution | |
| SPAN-CARE | In distribution | |
| CUSTOM CARE | In distribution | |
| SPAN-CARE | In distribution | |
| Custom Care LAL | In distribution | |
| APM/ APM II | In distribution | |
| The Topper | In distribution | |
| APM II | In distribution | |
| APM II | In distribution | |
| TOPPER PARAMOUNT 84 X 36 | In distribution | |
| PressureGaurd Custom Care LAL | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGuard MEM | In distribution | |
| SPAN-CARE | In distribution | |
| APM/ APM II | In distribution | |
| PROTOCOL | In distribution | |
| The Topper | In distribution | |
| EASY AIR LR | In distribution | |
| CUSTOM CARE LAL | In distribution | |
| PRESTO | In distribution | |
| CUSTOM CARE | In distribution | |
| PressureGuard Easy Air LR | In distribution | |
| APM/ APM II | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGuard Span Care Convertible | In distribution | |
| PROTOCOL | In distribution | |
| PressureGaurd Easy Air LR | In distribution | |
| PressureGuard Easy Air | In distribution | |
| APM-i | In distribution | |
| APM/ APM II | In distribution | |
| CUSTOM CARE | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGaurd Custom Care LAL | In distribution | |
| SPAN-CARE | In distribution | |
| APM Bariatric | In distribution | |
| EASY AIR | In distribution | |
| PressureGuard Easy Air LR | In distribution | |
| PressureGuard APM | In distribution | |
| PRESTO | In distribution | |
| APM Bariatric | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGuard MEM | In distribution | |
| CUSTOM CARE | In distribution | |
| The Topper | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGaurd Easy Air LR | In distribution | |
| CUSTOM CARE NP | In distribution | |
| EASY AIR LR | In distribution | |
| EASY AIR LR | In distribution | |
| The Topper | In distribution | |
| CUSTOM CARE | In distribution | |
| PressureGuard | In distribution | |
| EASY AIR XL CONTROL UNIT | In distribution | |
| EASY AIR LR | In distribution | |
| EASY AIR XL | In distribution | |
| EASY AIR XL | In distribution | |
| SPAN-CARE | In distribution | |
| APM/ APM II | In distribution | |
| PressureGaurd Easy Air LR | In distribution | |
| CUSTOM CARE | In distribution | |
| EASY AIR LR | In distribution | |
| Span Care Convertible | In distribution | |
| SPAN-CARE | In distribution | |
| PROTOCOL | In distribution | |
| The Topper | In distribution | |
| SPAN-CARE | In distribution | |
| APM/ APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| SPAN-CARE | In distribution | |
| CUSTOM CARE NP | In distribution | |
| APM/ APM II | In distribution | |
| PG APM2 | In distribution | |
| EASY AIR XL | In distribution | |
| OSKA SPAN CARE | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGuard APM2 | In distribution | |
| PressureGuard Span Care Convertible | In distribution | |
| OSKA APM2 | In distribution | |
| PressureGuard Span Care | In distribution | |
| PROTOCOL | In distribution | |
| OSKA SPAN CARE | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| APM-i | In distribution | |
| EASY AIR XL | In distribution | |
| EASY AIR LR | In distribution | |
| The Topper | In distribution | |
| PRESTO | In distribution | |
| CUSTOM CARE LAL | In distribution | |
| APM/ APM II | In distribution | |
| EASY AIR XL | In distribution | |
| PRESTO | In distribution | |
| APM2 | In distribution | |
| PressureGaurd Easy Air LR | In distribution | |
| EASY AIR | In distribution | |
| APM Bariatric | In distribution | |
| EASY AIR LR | In distribution | |
| PressureGuard APM | In distribution | |
| PressureGaurd Custom Care NP | In distribution | |
| PressureGaurd Span-Care | In distribution | |
| SPAN-CARE | In distribution | |
| PG APM2 | In distribution | |
| The Topper | In distribution | |
| OSKA APM2 | In distribution | |
| SPAN-CARE | In distribution | |
| APM-i | In distribution | |
| PressureGuard APM2 | In distribution | |
| SPAN-CARE | In distribution | |
| APM/ APM II | In distribution | |
| PressureGaurd Easy Air LR | In distribution | |
| EASY AIR LR | In distribution | |
| APM/ APM II | In distribution | |
| HERCULES | In distribution | |
| PressureGuard APM II | In distribution | |
| SPAN-CARE | In distribution | |
| Topper | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| SPAN-CARE | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| Span Care Convertible | In distribution | |
| EASY AIR LR | In distribution | |
| APM/ APM II | In distribution | |
| PG APM2 | In distribution | |
| The Topper | In distribution | |
| CUSTOM CARE | In distribution | |
| APM/ APM II | In distribution | |
| APM/ APM II | In distribution | |
| Custom Care Convertible | In distribution | |
| EASY AIR XL | In distribution | |
| EASY AIR | In distribution | |
| SPAN-CARE | In distribution | |
| CUSTOM CARE | In distribution | |
| PressureGuard APM | In distribution | |
| EASY AIR | In distribution | |
| APM/ APM II | In distribution | |
| APM/ APM II | In distribution | |
| SPAN-CARE | In distribution | |
| CUSTOM CARE | In distribution | |
| OSKA SPAN CARE | In distribution | |
| HERCULES | In distribution | |
| MEM | In distribution | |
| EASY AIR | In distribution | |
| PressureGuard APM2 | In distribution | |
| CUSTOM CARE | In distribution | |
| EASY AIR XL | In distribution | |
| EASY AIR LR | In distribution | |
| APM/ APM II | In distribution | |
| APM/ APM II | In distribution | |
| PG APM2 | In distribution | |
| APM-i | In distribution | |
| PressureGaurd Span-Care | In distribution | |
| SPAN-CARE | In distribution | |
| EASY AIR BARIATRIC | In distribution | |
| HERCULES | In distribution | |
| EASY AIR XL | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGaurd Custom Care LAL | In distribution | |
| SPAN-CARE | In distribution | |
| PressureGuard Easy Air | In distribution | |
| CUSTOM CARE | In distribution | |
| SPAN-CARE | In distribution | |
| SPAN-CARE | In distribution | |
| OSKA SPAN CARE | In distribution | |
| CUSTOM CARE | In distribution | |
| PressureGuard Span Care Convertible | In distribution | |
| The Topper | In distribution | |
| CUSTOM CARE LAL | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| PressureGuard Easy Air XL | In distribution | |
| CUSTOM CARE | In distribution | |
| The Topper | In distribution | |
| APM/ APM II | In distribution | |
| PressureGuard Span Care Convertible | In distribution | |
| The Topper | In distribution | |
| APM-i | In distribution | |
| PressureGuard | In distribution | |
| APM II | In distribution | |
| PressureGuard APM2 | In distribution | |
| APM/ APM II | In distribution | |
| PressureGuard Easy Air LR | In distribution | |
| PressureGaurd Custom Care NP | In distribution | |
| APM II | In distribution | |
| EASY AIR LR | In distribution | |
| PressureGaurd Span-Care | In distribution | |
| CUSTOM CARE LAL | In distribution | |
| The Topper | In distribution | |
| The Topper | In distribution | |
| APM/ APM II | In distribution | |
| PressureGaurd Custom Care LAL | In distribution | |
| CUSTOM CARE | In distribution |
Showing 250 of 286 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PressureGuard | Span-America Medical Systems, Inc. | 328 |
| 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.