510(k) K940582 ยท IRO Vibrator, Therapeutic
MASSAGING HELMET C.F. HANSEN DESIGN
| Applicant | Philco Ushuaia, Canada, CA |
| Decision | Substantially Equivalent for Some Indications, Jan 30, 1995 |
| Received | Feb 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940582
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.