K946186 is an FDA 510(k) clearance for the CHAL-2500. This device is classified as a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on August 14, 1995, 237 days after receiving the submission on December 20, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K946186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 20, 1994 |
| Decision Date | August 14, 1995 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5850 |