The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Model Hl-100 Portable Dc Elect. Therapeutic Unit.
| Device ID | K871421 |
| 510k Number | K871421 |
| Device Name: | MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT |
| Classification | Stimulator, Muscle, Powered |
| Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Contact | Morad Davoudzadeh |
| Correspondent | Morad Davoudzadeh FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-09 |
| Decision Date | 1988-01-22 |