Product code PPS
- Device name
- Sleeve, Head And Neck, Compressible
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5800
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Intended to move excess fluid from the target area to another area of the body.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816305022124 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022261 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022254 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022247 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022230 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022223 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022216 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022209 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022193 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022186 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022179 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022162 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022155 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022148 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022131 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022117 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022100 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022094 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022070 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022063 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022056 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305022049 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305021400 | Flexitouch Plus | Tactile Systems Technology, Inc. | 2017-10-31 |
| 00816305021875 | Flexitouch | Tactile Systems Technology, Inc. | 2017-05-05 |
| 00816305021868 | Flexitouch | Tactile Systems Technology, Inc. | 2017-05-05 |
| 00816305021851 | Flexitouch | Tactile Systems Technology, Inc. | 2017-05-05 |
| 00816305021592 | Flexitouch | Tactile Systems Technology, Inc. | 2017-05-05 |
| 00816305021356 | Flexitouch | Tactile Systems Technology, Inc. | 2016-10-07 |
| 00816305021349 | Flexitouch | Tactile Systems Technology, Inc. | 2016-10-07 |
| 00816305020106 | Flexitouch | Tactile Systems Technology, Inc. | 2016-09-20 |