The following data is part of a premarket notification filed by Medela Ag with the FDA for Invia Motion-endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/tubing Set 0.151, Invia Motion Carrying Case, Power Supply.
| Device ID | K161128 |
| 510k Number | K161128 |
| Device Name: | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Medela AG Lattichstrasse 4b Baar Zug, CH 6341 |
| Contact | Markus Butler |
| Correspondent | Adrienne Lenz Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, WI 53118 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-21 |
| Decision Date | 2016-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367053174 | K161128 | 000 |
| 07612367053167 | K161128 | 000 |
| 07612367052849 | K161128 | 000 |
| 07612367051248 | K161128 | 000 |