Handisol
2 catalogue numbers from UVB-150-1, listed by National Biological Corp., United States, under Light, Ultraviolet, Dermatological. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
27510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shenzhen GSD Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
| Shenzhen Peninsula Medical Group | Shenzhen | Guangdong | Manufacturer | 4 |
| Chongqing Peninsula Medical Technology Co., Ltd. | Chongqing | Chongqing | Repacker / relabeller | 2 |
| Shanghai Sigma High-Tech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | National Biological Corp., United States |
|---|---|
| FDA product code | FTC |
| Device type | Light, Ultraviolet, Dermatological |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4630 |
| Record published | 2024-04-03 |
| Record revised | 2025-10-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UVB-150-1 | In distribution | |
| UVB-150-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Daavlin | Daavlin Distributing Co., THE | 559 |
| National Biological Corporation | National Biological Corp. | 68 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 31 |
| Solarc/SolRx E-Series | Solarc Systems Inc. | 16 |
| UVBioTek | Medtek Lighting Corporation | 12 |
| Solarc/SolRx 100-Series | Solarc Systems Inc. | 7 |
| Solarc/SolRx 1000-Series | Solarc Systems Inc. | 7 |
| Solarc/SolRx 500-Series | Solarc Systems Inc. | 7 |
| Boston Aesthetics | Shenzhen Peninsula Medical Group | 4 |
| Panosol 6-3D | Daavlin Distributing Co., THE | 4 |
| Panosol 6 | Daavlin Distributing Co., THE | 4 |
| Panosol 6 | National Biological Corp. | 4 |
Showing 12 of 43. All products under Light, Ultraviolet, Dermatological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150912 | 2015-07-10 |
| K070934 | 2007-05-22 |
| K041212 | 2004-06-09 |
| K982082 | 1998-10-28 |
| K934808 | 1993-12-16 |
| K924969 | 1993-02-23 |
| K924077 | 1992-11-20 |
| K904428 | 1990-12-24 |
| K904426 | 1990-12-24 |
| K904427 | 1990-12-24 |
| K885029 | 1989-06-02 |
| K885026 | 1989-06-02 |
| K885025 | 1989-01-09 |
| K882722 | 1988-08-30 |
| K872651 | 1987-07-27 |
| K872649 | 1987-07-27 |
| K872707 | 1987-07-27 |
| K872706 | 1987-07-27 |
| K872650 | 1987-07-27 |
| K872604 | 1987-07-24 |
| K872605 | 1987-07-24 |
| K864546 | 1987-01-09 |
| K827890 | 1982-08-23 |
| K761186 | 1977-02-28 |
| K761188 | 1977-02-28 |
| K761189 | 1977-02-28 |
| K761187 | 1977-02-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-01-27 | Class II | Employee error | The wiring may allow the lamps to turn on with the key switch rather than the timer. | 7 units | 2019-02-08 |
| 2013-04-09 | Class III | Labeling mix-ups | The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. | 124 units | 2014-02-24 |
| 2013-04-08 | Class III | Labeling mix-ups | The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. | 6 units | 2014-02-24 |
| 2008-02-19 | Not classified | Software design | Software allows operator to override “low line voltage” error warning and store light intensity value. | 48 Units | 2011-09-20 |
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.