The following data is part of a premarket notification filed by Dynamic Air, Inc. with the FDA for Travelair Portable Compression System.
Device ID | K022340 |
510k Number | K022340 |
Device Name: | TRAVELAIR PORTABLE COMPRESSION SYSTEM |
Classification | Sleeve, Limb, Compressible |
Applicant | DYNAMIC AIR, INC. 3495 BANKHEAD HIGHWAY SUITE A Atlanta, GA 30331 |
Contact | Brent Knight |
Correspondent | Brent Knight DYNAMIC AIR, INC. 3495 BANKHEAD HIGHWAY SUITE A Atlanta, GA 30331 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-18 |
Decision Date | 2003-02-19 |
Summary: | summary |