The following data is part of a premarket notification filed by Elite Medical Supply Of New York, Llc with the FDA for Ems100 Tri-wave Combination Stimulator.
| Device ID | K171387 |
| 510k Number | K171387 |
| Device Name: | EMS100 Tri-Wave Combination Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Elite Medical Supply Of New York, LLC 1900 Ridge Rd. Suite #125 West Seneca, NY 14224 |
| Contact | John Mcgrady |
| Correspondent | John Mcgrady Elite Medical Supply Of New York, LLC 1900 Ridge Rd. Suite #125 West Seneca, NY 14224 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-11 |
| Decision Date | 2017-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860019001623 | K171387 | 000 |