IsoFlex LAL
12 catalogue numbers from 2860, listed by Stryker GmbH, Switzerland, under Bed, Flotation Therapy, Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
12catalogue numbers in this listing
2recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| SHL Healthcare Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | IOQ |
| Device type | Bed, Flotation Therapy, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5170 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -40 to 140 °F; Storage environment humidity 10 to 100 % RH; Handling environment humidity 10 to 100 % RH; Handling environment temperature -40 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution | |
| 2860 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| K-3 Aire-Zone | KAP Medical | 60 |
| Citadel | Arjohuntleigh AB | 53 |
| Bed, Flotation Therapy, Powered | Carilex Medical, Inc. | 44 |
| pro+ | Hill-ROM, Inc. | 34 |
| Multicare | L I N E T spol. s r.o. | 32 |
| K-3oem EZ-Zone | KAP Medical | 30 |
| K-3oem EZ-Aire | KAP Medical | 29 |
| Progressa+ surface | Hill-Rom de México, S. de R.L. de C.V. | 26 |
| Stryker Air | Tridien Medical | 22 |
| Progressa® Surface | Hill-ROM, Inc. | 21 |
| P310 Surface | Hill-ROM, Inc. | 16 |
| TotalCare® P500 Surface | Hill-ROM, Inc. | 13 |
Showing 12 of 74. All products under Bed, Flotation Therapy, 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 |
|---|---|---|---|---|---|
| 2018-08-13 | Class II | Mixed-up of materials/components | Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. | 243 | 2020-05-21 |
| 2013-07-12 | Class II | Nonconforming Material/Component | Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR” surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it w | 586 units | 2014-09-11 |
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.