The following data is part of a premarket notification filed by 138 Medical Supplies, Inc. with the FDA for Ems Jumper Ii Dual Channel Neuromuscular Stimulator System, Model E-188.
| Device ID | K000741 |
| 510k Number | K000741 |
| Device Name: | EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | 138 MEDICAL SUPPLIES, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk 138 MEDICAL SUPPLIES, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-07 |
| Decision Date | 2001-10-24 |