The following data is part of a premarket notification filed by Physicians Consulting, Inc. with the FDA for Krd Pl 2000 Controlled Passive Motion (cpm) Portable.
| Device ID | K952369 |
| 510k Number | K952369 |
| Device Name: | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE |
| Classification | Exerciser, Powered |
| Applicant | PHYSICIANS CONSULTING, INC. 100 CONGREEE AVE. SUITE 1010 Austin, TX 78701 -4042 |
| Contact | Gregory E Johnson |
| Correspondent | Gregory E Johnson PHYSICIANS CONSULTING, INC. 100 CONGREEE AVE. SUITE 1010 Austin, TX 78701 -4042 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-08-07 |