Submission Details
| 510(k) Number | K940683 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | February 10, 1994 |
| Decision Date | June 09, 1994 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K940683 is an FDA 510(k) clearance for the WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Wahl Clipper Corp. (Sterling, US). The FDA issued a Cleared decision on June 9, 1994, 119 days after receiving the submission on February 10, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K940683 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | February 10, 1994 |
| Decision Date | June 09, 1994 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ISA — Massager, Therapeutic, Electric |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5660 |