The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Threshold(tm) Inspiratory Muscle Trainer.
| Device ID | K870514 |
| 510k Number | K870514 |
| Device Name: | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER |
| 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 | 1987-02-05 |
| Decision Date | 1987-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730001029 | K870514 | 000 |
| 00383730000657 | K870514 | 000 |
| 00383730000664 | K870514 | 000 |
| 00383730000671 | K870514 | 000 |
| 00383730000688 | K870514 | 000 |
| 00383730000695 | K870514 | 000 |
| 00383730000701 | K870514 | 000 |
| 00383730000718 | K870514 | 000 |
| 00383730001012 | K870514 | 000 |
| 00383730000121 | K870514 | 000 |