The following data is part of a premarket notification filed by Paw, Llc with the FDA for Actiband.
Device ID | K022404 |
510k Number | K022404 |
Device Name: | ACTIBAND |
Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
Applicant | PAW, LLC 5540 HIDDEN WATERS LN. Frederick, MD 21703 |
Contact | Andrew J Whelan |
Correspondent | Andrew J Whelan PAW, LLC 5540 HIDDEN WATERS LN. Frederick, MD 21703 |
Product Code | ILX |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-23 |
Decision Date | 2002-08-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACTIBAND 76472071 3081125 Dead/Cancelled |
Cambridge Neurotechnology Limited 2002-11-29 |