The following data is part of a premarket notification filed by Talley Group Ltd. with the FDA for Multipulse Sequential Compression Unit.
Device ID | K914774 |
510k Number | K914774 |
Device Name: | MULTIPULSE SEQUENTIAL COMPRESSION UNIT |
Classification | Massager, Powered Inflatable Tube |
Applicant | TALLEY GROUP LTD. 815 TERMINAL RD. Lansing, MI 48906 |
Contact | Van Dyke |
Correspondent | Van Dyke TALLEY GROUP LTD. 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 | 1991-10-23 |
Decision Date | 1992-02-11 |