510(k) K964397 ยท ILY Lamp, Infrared, Therapeutic Heating
THERAPIK
| Applicant | The Jenex Corporation, Pawtucket RI, US |
| Decision | Substantially Equivalent, Nov 4, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964397
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.