IMC
12 FDA 510(k) clearances · Product code
52 daysmedian time to decision
85 days90th percentile
12clearances measured
FDA profile
- Official device name
- Bath, Paraffin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5110
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 1998: 2 · 2001: 3 · 2002: 4 · 2003: 2 · 2007: 7 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) (K093100) | Shenzhen Comfort Technology Co., Ltd. | 2009-11-24 |
| MOISTURESTAY (REVLON) (K022626) | Raymond Industrial, Ltd. | 2002-10-29 |
| SOFTIQUE, MODEL GI 11001 (K013707) | Global TV Concepts, Ltd. | 2002-02-01 |
| REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 (K013328) | Remington Products Company, LLC | 2001-12-03 |
| PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA (K001860) | Homedics, Inc. | 2000-08-10 |
| PARAMED PARAFFIN WARMER (K991427) | Divi Intl. Co. | 1999-08-13 |
| PARA-CARE (K980718) | Chattanooga Group, Inc. | 1998-03-27 |
| R1124 & R1686 PARAFFIN (K861344) | Tri W-G, Inc. | 1986-05-27 |
| R1363 PARAFFIN (K861346) | Tri W-G, Inc. | 1986-05-02 |
| PARA THERM BATH (K842423) | Grimm Scientific Industries, Inc. | 1984-06-28 |
| THERMAMED BATH (K833631) | Bernlit Enterprises, Inc. | 1983-11-28 |
| MADDATHERM PARAFFIN BATH (K770170) | Techhnilab Instruments, Inc. | 1977-01-28 |
Track IMC automatically
Every clearance here is in the API, with alerts when new ones post.