The following data is part of a premarket notification filed by Pegasus Airwave, Inc. with the FDA for Pegasus Proactive Wheelchair Cushion.
Device ID | K930742 |
510k Number | K930742 |
Device Name: | PEGASUS PROACTIVE WHEELCHAIR CUSHION |
Classification | Wheelchair, Powered |
Applicant | PEGASUS AIRWAVE, INC. 640 SOUTH MILITAY TRAIL Deerfield Beach, FL 33442 |
Contact | Welch |
Correspondent | Welch PEGASUS AIRWAVE, INC. 640 SOUTH MILITAY TRAIL Deerfield Beach, FL 33442 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-12 |
Decision Date | 1994-03-31 |