Bodicool Wave Triangle
Bodicool Wave Triangle Cover Size 14
3manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Dongguan Lanke Silicone Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| BUY Asia Enterprise Ltd | Dongguan | Guangdong | Private-label distributor | 22 |
Record
| Listed by | Trulife, Inc., United States |
|---|---|
| FDA product code | NOJ |
| Device type | Prosthesis, Breast, External, No Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 495 06 | In distribution | |
| C495 03 | In distribution | |
| 495 14 | In distribution | |
| C495 09 | In distribution | |
| C495 14 | In distribution | |
| C495 05 | In distribution | |
| 495 13 | In distribution | |
| C495 06 | In distribution | |
| C495 07 | In distribution | |
| C495 02 | In distribution | |
| 495 04 | In distribution | |
| C495 13 | In distribution | |
| C495 11 | In distribution | |
| C495 01 | In distribution | |
| C495 04 | In distribution | |
| 495 08 | In distribution | |
| 495 09 | In distribution | |
| 495 03 | In distribution | |
| 495 11 | In distribution | |
| 495 12 | In distribution | |
| C495 12 | In distribution | |
| 495 05 | In distribution | |
| 495 07 | In distribution | |
| 495 10 | In distribution | |
| C495 10 | In distribution | |
| 495 01 | In distribution | |
| 495 02 | In distribution | |
| C495 08 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 179 |
| A Supreme | Trulife, Inc. | 84 |
| E Supreme | Trulife, Inc. | 34 |
| Bodicool Triangle | Trulife, Inc. | 31 |
| Silk Xtend | Trulife, Inc. | 28 |
| Silk A Supreme | Trulife, Inc. | 28 |
| Bella | Trulife, Inc. | 26 |
| Silk Lite Partial | Trulife, Inc. | 26 |
| Impressions II | Trulife, Inc. | 23 |
| Sublime Arís | Trulife, Inc. | 21 |
| Luna | Trulife, Inc. | 20 |
| Symphony | Trulife, Inc. | 18 |
Showing 12 of 37. All products under Prosthesis, Breast, External, No Adhesive
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.