The following data is part of a premarket notification filed by Longo Industries with the FDA for Physio Hab.
Device ID | K941033 |
510k Number | K941033 |
Device Name: | PHYSIO HAB |
Classification | Exerciser, Measuring |
Applicant | LONGO INDUSTRIES 1800 LIBERTY DR. Pueblo, CO 81006 |
Contact | Matthew C Longo |
Correspondent | Matthew C Longo LONGO INDUSTRIES 1800 LIBERTY DR. Pueblo, CO 81006 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-04 |
Decision Date | 1995-02-27 |