The following data is part of a premarket notification filed by Progressive Medical Technology, Inc. with the FDA for Talley Tm200 Intermttent Compression Unit.
| Device ID | K915638 |
| 510k Number | K915638 |
| Device Name: | TALLEY TM200 INTERMTTENT COMPRESSION UNIT |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | PROGRESSIVE MEDICAL TECHNOLOGY, INC. 815 TERMINAL RD. Lansing, MI 48906 |
| Contact | Van Dyke |
| Correspondent | Van Dyke PROGRESSIVE MEDICAL TECHNOLOGY, INC. 815 TERMINAL RD. Lansing, MI 48906 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1992-02-11 |