The following data is part of a premarket notification filed by Arjohuntleigh Polska Sp Z.o.o. with the FDA for Flowtron Acs800 Pump And Tri Pulse Garments.
| Device ID | K133119 |
| 510k Number | K133119 |
| Device Name: | FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ARJOHUNTLEIGH POLSKA SP Z.O.O. 35 PORTMANMOOR ROAD Cardiff, S. Glamorgan, GB Cf24 5hn |
| Contact | David Moynham |
| Correspondent | David Moynham ARJOHUNTLEIGH POLSKA SP Z.O.O. 35 PORTMANMOOR ROAD Cardiff, S. Glamorgan, GB Cf24 5hn |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055982700344 | K133119 | 000 |
| 15055982700822 | K133119 | 000 |
| 15055982700839 | K133119 | 000 |
| 15055982700846 | K133119 | 000 |
| 15055982700853 | K133119 | 000 |
| 05055982700214 | K133119 | 000 |
| 05055982700221 | K133119 | 000 |
| 05055982700238 | K133119 | 000 |
| 05055982700245 | K133119 | 000 |
| 05055982700337 | K133119 | 000 |
| 15055982700815 | K133119 | 000 |