The following data is part of a premarket notification filed by Valmed Corp. with the FDA for P4-fitness.
| Device ID | K031611 |
| 510k Number | K031611 |
| Device Name: | P4-FITNESS |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | VALMED CORP. 5080 NORTH OCEAN DRIVE 1A Singer Island, FL 33404 |
| Contact | Guy Poitout |
| Correspondent | Guy Poitout VALMED CORP. 5080 NORTH OCEAN DRIVE 1A Singer Island, FL 33404 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-22 |
| Decision Date | 2004-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640174840007 | K031611 | 000 |