Table, Obstetrical, Ac-Powered (And Accessories)
8 catalogue numbers from 4701, listed by Stryker GmbH, Switzerland, under Table, Obstetrical, Ac-Powered (And Accessories). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Hebei (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Kanghui Medical Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 11 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HDD |
| Device type | Table, Obstetrical, Ac-Powered (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4900 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K950889 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 75 % RH; Handling environment atmospheric pressure 500 to 1060 KiloPascal; Storage environment atmospheric pressure 500 to 1060 KiloPascal; Handling environment humidity 10 to 75 % RH; Storage environment temperature -4 to 104 °F; Handling environment temperature -4 to 104 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4701 | In distribution | |
| 4701 | In distribution | |
| 4701 | In distribution | |
| 4701 | In distribution | |
| 4701 | In distribution | |
| 4701 | In distribution | |
| 4701 | In distribution | |
| 4701 | In distribution |
Same Product Code
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950889 | 1995-10-16 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | 510(k) number | 2005-03-31 | Not classified | Other | Trendelenburg and reverse trendelenburg features may not function. | 31 | 2005-05-09 |
| Stryker GmbH | 510(k) number | 2004-01-26 | Not classified | Other | A potential shock hazard exists if the night light is damaged. | 1391 | 2004-06-07 |
| Stryker GmbH | 510(k) number | 2004-01-26 | Not classified | Other | A potential shock hazard exists if the night light is damaged. | 763 | 2004-06-07 |
| Stryker GmbH | 510(k) number | 2004-01-26 | Not classified | Other | A potential shock hazard exists if the night light is damaged. | 242 | 2004-06-07 |
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.