The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Roadrunner, Pep Therapy Device.
| Device ID | K991561 |
| 510k Number | K991561 |
| Device Name: | ROADRUNNER, PEP THERAPY DEVICE |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163 |
| Contact | Larry Weinstein |
| Correspondent | Larry Weinstein DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-04 |
| Decision Date | 1999-11-10 |
| Summary: | summary |