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 |