The following data is part of a premarket notification filed by Cropper Medical, Inc. with the FDA for Continuous Passive Motion Patient Kit Or Re. Pad.
Device ID | K871012 |
510k Number | K871012 |
Device Name: | CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD |
Classification | Exerciser, Powered |
Applicant | CROPPER MEDICAL, INC. 330 HERSHEY ST. (PER DO MEMO, OOB) Ashland, OR 97520 |
Contact | Dean E Cropper |
Correspondent | Dean E Cropper CROPPER MEDICAL, INC. 330 HERSHEY ST. (PER DO MEMO, OOB) Ashland, OR 97520 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-13 |
Decision Date | 1987-03-25 |