Span-America
GEL-T 16X16 W/CVR/SLV (P01409) (Replaced BY 8016-05)
52manufacturers in China registered for this device type
270catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (8), Fujian (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Jiangsu Yishun Medical Equipment Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 10 |
| Shenzhen Lantise Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Ehob (Shanghai) Medical Products Co., Ltd. | Pudong | Shanghai | Contract manufacturer | 8 |
| Shanghai Ehob Health Care Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| EHOB(JiaXing) Medical Product Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Dongjilian Medical Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Good Horse Toys AND Gifts Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Dongguan IMS (FE) Electro-Mechanical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 52. All 52 manufacturers in China registered for Cushion, Flotation
Record
| Listed by | Span-America Medical Systems, Inc., United States |
|---|---|
| FDA product code | KIC |
| Device type | Cushion, Flotation |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3175 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
| Record revised | 2025-07-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-08-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Geomattress | In distribution | |
| EQUALIZER | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| SHORT WAVE | In distribution | |
| Geomattress | In distribution | |
| EQUALIZER | In distribution | |
| WEDGE | In distribution | |
| EQUALIZER | In distribution | |
| Geomattress | In distribution | |
| WEDGE | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| CONTOUR | In distribution | |
| SPAN AIDS | In distribution | |
| Isch Dish | In distribution | |
| PRT | In distribution | |
| CONTOUR | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| GEOMATT | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| SPAN AIDS | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| WEDGE | In distribution | |
| EQUALIZER | In distribution | |
| SPAN AIDS | In distribution | |
| GeoMatt | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Isch Dish | In distribution | |
| ISCH DISH | In distribution | |
| EQUALIZER | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| SPAN AIDS | In distribution | |
| Geomattress | In distribution | |
| Span Aids | In distribution | |
| SPAN AIDS | In distribution | |
| CONTOUR | In distribution | |
| SPAN AIDS | In distribution | |
| EQUALIZER | In distribution | |
| GeoMatt | In distribution | |
| EQUALIZER | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| Equalizer | In distribution | |
| GEO WAVE | In distribution | |
| SPAN AIDS | In distribution | |
| PRT | In distribution | |
| Geomattress | In distribution | |
| GEO WAVE | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| EQUALIZER | In distribution | |
| Span Aids | In distribution | |
| Geomattress | In distribution | |
| Span Aids | In distribution | |
| CROSSCUT | In distribution | |
| Span Aids | In distribution | |
| SHORT WAVE | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Convoluted Cushion | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| SPAN AIDS | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Isch Dish | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| GEO WAVE | In distribution | |
| Span Aids | In distribution | |
| CONTOUR | In distribution | |
| EQUALIZER | In distribution | |
| WEDGE | In distribution | |
| Geomattress | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| CROSSCUT | In distribution | |
| CONTOUR | In distribution | |
| GeoMatt | In distribution | |
| PRT | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| GEL-T | In distribution | |
| SHORT WAVE | In distribution | |
| Convoluted Cushion | In distribution | |
| Span Aids | In distribution | |
| SPAN AIDS | In distribution | |
| Gel-T | In distribution | |
| Span Aids | In distribution | |
| EQUALIZER | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Geomattress | In distribution | |
| Span Aids | In distribution | |
| SHORT WAVE | In distribution | |
| CONTOUR | In distribution | |
| WEDGE | In distribution | |
| Gel-T | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| EZ-DISH | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| Convoluted Cushion | In distribution | |
| EQUALIZER | In distribution | |
| Span Aids | In distribution | |
| WEDGE | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| Span Aids | In distribution | |
| Isch Dish | In distribution | |
| SOFT SKIN | In distribution | |
| Span Aids | In distribution | |
| Isch Dish | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| GEL-T | In distribution | |
| Span Aids | In distribution | |
| GEO WAVE | In distribution | |
| Span Aids | In distribution | |
| SPAN AIDS | In distribution | |
| WEDGE | In distribution | |
| PRT | In distribution | |
| Convoluted Rollpack | In distribution | |
| CROSSCUT | In distribution | |
| Equalizer | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| WEDGE | In distribution | |
| EQUALIZER | In distribution | |
| Geomattress | In distribution | |
| CONTOUR | In distribution | |
| EQUALIZER | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| SPAN AIDS | In distribution | |
| Gel-T | In distribution | |
| SHORT WAVE | In distribution | |
| PRT | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| EQUALIZER | In distribution | |
| EQUALIZER | In distribution | |
| Geomattress | In distribution | |
| CONTOUR | In distribution | |
| CONTOUR | In distribution | |
| WEDGE | In distribution | |
| GeoMatt | In distribution | |
| GeoMatt | In distribution | |
| Span Aids | In distribution | |
| WEDGE | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| CROSSCUT | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| CONTOUR | In distribution | |
| CROSSCUT | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Isch Dish | In distribution | |
| CROSSCUT | In distribution | |
| WEDGE | In distribution | |
| Span Aids | In distribution | |
| CROSSCUT | In distribution | |
| SPAN AIDS | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| CONTOUR | In distribution | |
| EQUALIZER | In distribution | |
| EZ-DISH | In distribution | |
| CROSSCUT | In distribution | |
| GEO WAVE | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| Seating | In distribution | |
| EQUALIZER | In distribution | |
| GEO WAVE | In distribution | |
| WEDGE | In distribution | |
| EQUALIZER | In distribution | |
| Isch Dish | In distribution | |
| EZ-DISH | In distribution | |
| EQUALIZER | In distribution | |
| Equalizer | In distribution | |
| SPAN AIDS | In distribution | |
| PRT | In distribution | |
| PRT | In distribution | |
| GeoMatt | In distribution | |
| Isch Dish | In distribution | |
| Gel-T | In distribution | |
| GeoMatt | In distribution | |
| Gel-T | In distribution | |
| SHORT WAVE | In distribution | |
| Span Aids | In distribution | |
| Geomattress | In distribution | |
| EQUALIZER | In distribution | |
| SPAN AIDS | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| PRT | In distribution | |
| Convoluted Cushion | In distribution | |
| ISCH DISH | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| GeoMatt | In distribution | |
| GEO WAVE | In distribution | |
| EQUALIZER | In distribution | |
| GeoMatt | In distribution | |
| WEDGE | In distribution | |
| EZ-DISH | In distribution | |
| EZ-DISH | In distribution | |
| EZ-DISH | In distribution | |
| GeoMatt | In distribution | |
| Span Aids | In distribution | |
| Span Aids | In distribution | |
| Gel-T | In distribution | |
| GEOMATT | In distribution | |
| PRT | In distribution | |
| GEO WAVE | In distribution | |
| Span Aids | In distribution | |
| CONTOUR | In distribution | |
| Convoluted Cushion | In distribution | |
| Soft Pedal | Withdrawn | |
| Isch Dish | Withdrawn | |
| Isch Dish | Withdrawn | |
| ISCH DISH | Withdrawn |
Showing 250 of 270 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varilite | Cascade Designs, Inc. | 736 |
| Star | Ki Mobility | 318 |
| Roho High Profile Single Compartment Cushion | Roho, Inc. | 172 |
| Action® | Action Products, Inc. | 136 |
| Roho Quadtro Select High Profile Cushion | Roho, Inc. | 103 |
| Roho MID Profile Single Compartment Cushion | Roho, Inc. | 93 |
| Roho LOW Profile Single Compartment Cushion | Roho, Inc. | 58 |
| Roho Hybrid Elite Dual Compartment Cushion | Roho, Inc. | 57 |
| Roho Hybrid Elite SR Single Compartment Cushion | Roho, Inc. | 56 |
| Drivemedical | Drive DeVilbiss Healthcare | 56 |
| Roho Contour Select Cushion | Roho, Inc. | 52 |
| Waffle | Ehob, Inc. | 47 |
Showing 12 of 127. All products under Cushion, Flotation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960189 | 1996-02-07 |
| K954117 | 1995-10-13 |
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.