The following data is part of a premarket notification filed by Ndm Acquisition Corp. with the FDA for Act-one Advanced Compression Technology Foot Pump.
| Device ID | K943287 |
| 510k Number | K943287 |
| Device Name: | ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP |
| Classification | Sleeve, Limb, Compressible |
| Applicant | NDM ACQUISITION CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Contact | Donald E Koopman |
| Correspondent | Donald E Koopman NDM ACQUISITION CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-08 |
| Decision Date | 1994-12-27 |