ErgoLite
Upgrade From Halog TO LED Ergolite LED W/ External 100-240 VAC Power
5manufacturers in China registered for this device type
8catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (2), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Kanghuajianye Medical Materials Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 1 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Aadco Medical, Inc., United States |
|---|---|
| FDA product code | IWX |
| Device type | Barrier, Control Panel, X-Ray, Movable |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSP-511LX | In distribution | |
| OSP-515NF | In distribution | |
| OSP-515 | In distribution | |
| OSP-511H | In distribution | |
| OSP-511LXUPGR | In distribution | |
| OSP-515X | In distribution | |
| OSP-511LED | In distribution | |
| OSP-511HNF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aadco | Aadco Medical, Inc. | 214 |
| Hercules | Aadco Medical, Inc. | 126 |
| WD | Mavig Gmbh | 63 |
| MRI-Safe | Aadco Medical, Inc. | 46 |
| Image Diagnostics, Inc | Image Diagnostics, Inc. | 21 |
| ScatPad | Cardio Medical Products, Inc. | 18 |
| Techno-Aide | Techno-Aide, Inc. | 15 |
| Kenex | Kenex (Electro-Medical) Ltd. | 15 |
| MasterPeace | Texray AB | 14 |
| PlastCare | Proguard Health Inc. | 5 |
| Britedent | Bright Supply Inc | 4 |
| Dental City | ICP, Inc. | 3 |
Showing 12 of 20. All products under Barrier, Control Panel, X-Ray, Movable
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-11-01 | Not classified | Device Design | Screws may become loose from the mounted shield compromising stability | 324 units | 2012-05-02 |
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.