The following data is part of a premarket notification filed by Innovative Therapy Products, Inc. with the FDA for Itp-hvpc Galvanic Stimulator.
Device ID | K943007 |
510k Number | K943007 |
Device Name: | ITP-HVPC GALVANIC STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | INNOVATIVE THERAPY PRODUCTS, INC. 4004 ST. ELIZABETH Kenner, LA 70065 |
Contact | William G Roe |
Correspondent | William G Roe INNOVATIVE THERAPY PRODUCTS, INC. 4004 ST. ELIZABETH Kenner, LA 70065 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-11 |
Decision Date | 1995-10-26 |