The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Chal-2500.
| Device ID | K946186 |
| 510k Number | K946186 |
| Device Name: | CHAL-2500 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-08-14 |