The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Walkertalker.
Device ID | K933207 |
510k Number | K933207 |
Device Name: | WALKERTALKER |
Classification | Wheelchair, Powered |
Applicant | PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
Contact | Dave Hershberger |
Correspondent | Dave Hershberger PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
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 | 1993-07-01 |
Decision Date | 1994-03-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WALKERTALKER 76413725 not registered Dead/Abandoned |
MachineTalker, Inc. 2002-05-29 |