Pressure Therapy System PT1003
FDA 510(k) clearance K192358 · decided 2020-04-23
Clearance details
- K-number
- K192358
- Device name
- Pressure Therapy System PT1003
- Applicant
- Xiamen Senyang Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-29
- Decision date
- 2020-04-23
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Xinglin Xiamen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to tempor recall (Z-1398-2023) | Compass Health Brands (Corporate Office) | 2023-04-18 |