Synergy® Surface
Catalogue number P004651CAP, listed by Hill-ROM, Inc., United States, under Bed, Flotation Therapy, Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
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 | Hill-ROM, Inc., United States |
|---|---|
| FDA product code | IOQ |
| Device type | Bed, Flotation Therapy, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2023-12-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P004651CAP | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143414 | 2015-03-10 |
| K122473 | 2013-06-03 |
| K970636 | 1997-08-26 |
| K964873 | 1997-07-03 |
| K970295 | 1997-05-16 |
| K951001 | 1995-06-27 |
| K945729 | 1995-02-27 |
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 |
|---|---|---|---|---|---|
| 2013-05-30 | Class II | Device Design | When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to | 4,121 Units | 2014-04-17 |
| 2013-02-26 | Class II | Software design | In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritati | 309 | 2014-04-16 |
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.