Swiss Dolorclast
DolorClast Radial is a portable pressure-pulse system for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue. It uses…
DolorClast Radial is a portable pressure-pulse system for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue. It uses a console with an integrated air compressor and a handheld applicator.
Compressed air drives a projectile against the applicator head to create radial pressure pulses. A trigger on the handpiece activates the pulses, which pass through coupling gel on the skin to the targeted tissue.
Listed Item
DolorClast Radial
Treatment Controls
The console sets pulse intensity and frequency, with pressure settings from 1 to 4 bar and frequencies from 1 to 25 Hz. Interchangeable applicator heads provide different contact sizes, and the operator sets the number of pulses for treatment.
Who Else Makes It
Concentrated in Guangdong (213), Zhejiang (102), Fujian (43). 45 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Shenzhen Roundwhale Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Zhangzhou Easepal Innovation Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 7 |
| Shenzhen Xiangzhida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Alphay Medical Device Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Taizhou Rapson Glasses Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 6 |
Showing 12 of 437. All 437 manufacturers in China registered for Massager, Therapeutic, Electric
Record
| Listed by | E.M.S. Electro Medical Systems S.A., Switzerland |
|---|---|
| FDA product code | ISA |
| Device type | Massager, Therapeutic, Electric |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5660 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220538 |
| Record published | 2022-09-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 85 % RH; Storage environment temperature -10 to 30 °C; Handling environment humidity 35 to 65 % RH; Handling environment temperature 10 to 30 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Human Touch | Human Touch, LLC. | 190 |
| Homedics | Health Care Massage Branch of Zhangzhou Easepal Industrial Corporation | 102 |
| Conair | Conair LLC. | 87 |
| Sharper Image | Merchsource LLC | 62 |
| Renpho | Joicom Corporation | 59 |
| 3H | 3H Co., Ltd. | 48 |
| silverfox | Silverfox Corporation Limited | 35 |
| Thermage | Solta Medical, Inc. | 35 |
| Renpho Eye Massager | Joicom Corporation | 32 |
| Homedics | Smart Home Branch of Zhangzhou Easepal Industrial Corporation | 28 |
| G5® | General Physiotherapy, Inc. | 26 |
| Homedics | Zhangzhou Easepal Innovation Co., Ltd. | 23 |
Showing 12 of 249. All products under Massager, Therapeutic, Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220538 | 2022-07-11 |
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.