PearlFit
3 catalogue numbers from PearlFit Forehead Kit, listed by Pearl Inc., United States, under Cradle, Patient, Radiologic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Pearl Inc., United States |
|---|---|
| FDA product code | KXH |
| Device type | Cradle, Patient, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1830 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-17 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PearlFit Forehead Kit | In distribution | |
| PearlFit Wedge 56x50x25 NUC Vac | In distribution | |
| PearlFit Wedge 56x50x25 blue | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| pearltec | Pearl Inc. | 27 |
| ProFoam | Pearl Inc. | 22 |
| Moldcare RI II | Alcare Co., Ltd. | 11 |
| Moldcare | IZI Medical Products LLC | 6 |
| AccuBoost | Advanced Radiation Therapy, LLC | 5 |
| ProBelt | Pearl Inc. | 2 |
| ProFoam Wedge 18x23x10 30° | Pearl Inc. | 1 |
| ProBelt 50 VH | Pearl Inc. | 1 |
| PearlFit Inlay Head | Pearl Inc. | 1 |
| ProBelt 350 Wrap | Pearl Inc. | 1 |
| Small U Head Cushions | Octostop, Inc. | 1 |
| FoamFit Plate 18x8x2 | Pearl Inc. | 1 |
Showing 12 of 137. All products under Cradle, Patient, Radiologic
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.