The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which…
The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s)
Who Else Makes It
Concentrated in Hebei (3), Beijing (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 4 to 40 °C; Storage environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Storage environment humidity 30 to 75 % RH; Storage environment atmospheric pressure 82 to 106 KiloPascal |
| Packaging | Box |
| Sizes | Weight 21 kg; depth 459 mm; width 400 mm; height 218 mm |
| UDI direct marking | Exempt |
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.