The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Digital Electronic Myo-graph (muscle Analyzer).
Device ID | K862128 |
510k Number | K862128 |
Device Name: | DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER) |
Classification | Goniometer, Ac-powered |
Applicant | HEALTH PRODUCTS, INC. 1383-30 VETERANS MEMORIAL HGWY Hauppauge, NY 11788 |
Contact | Del Giorno |
Correspondent | Del Giorno HEALTH PRODUCTS, INC. 1383-30 VETERANS MEMORIAL HGWY Hauppauge, NY 11788 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-04 |
Decision Date | 1986-07-11 |