The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Pflex Em(tm) (exercise Monitor).
| Device ID | K864719 |
| 510k Number | K864719 |
| Device Name: | PFLEX EM(TM) (EXERCISE MONITOR) |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Contact | Mark J Flanick |
| Correspondent | Mark J Flanick HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-03 |
| Decision Date | 1987-03-16 |