FDA product code IMC: Bath, Paraffin
IMC is the FDA product code for bath, paraffin. It is a Class II device, regulated under 21 CFR 890.5110 and reviewed by the Physical Medicine panel. FDA has cleared 12 510(k) submissions under IMC, from 11 different applicants. The average 510(k) review took 50 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Bath, Paraffin |
| Device class | Class II |
| Regulation | 21 CFR 890.5110 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IMC clearance
Top IMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tri W-G, Inc. | 2 | 1986-05-27 |
| Shenzhen Comfort Technology Co., Ltd. | 1 | 2009-11-24 |
| Raymond Industrial, Ltd. | 1 | 2002-10-29 |
| Global TV Concepts, Ltd. | 1 | 2002-02-01 |
| Remington Products Company, LLC | 1 | 2001-12-03 |
6 more applicants have IMC clearances. See the full list in Caduvo.
Most recent IMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093100 | Shenzhen Comfort Technology Co., Ltd. | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) | 2009-11-24 | 54 |
| K022626 | Raymond Industrial, Ltd. | MOISTURESTAY (REVLON) | 2002-10-29 | 83 |
| K013707 | Global TV Concepts, Ltd. | SOFTIQUE, MODEL GI 11001 | 2002-02-01 | 85 |
| K013328 | Remington Products Company, LLC | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | 2001-12-03 | 59 |
| K001860 | Homedics, Inc. | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | 2000-08-10 | 52 |
Recalls for IMC devices
openFDA lists no recalls for product code IMC.
Frequently asked questions
What is FDA product code IMC?
IMC is the FDA product code for bath, paraffin. It is a Class II device, regulated under 21 CFR 890.5110 and reviewed by the Physical Medicine panel.
What device class is IMC?
Class II, regulation 21 CFR 890.5110. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMC?
Across 12 cleared submissions the average was 50 days from receipt to decision (median 51).
Which companies have the most IMC clearances?
Tri W-G, Inc. (2); Shenzhen Comfort Technology Co., Ltd. (1); Raymond Industrial, Ltd. (1); Global TV Concepts, Ltd. (1); Remington Products Company, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IMC
- Run a recall and safety report across every IMC manufacturer
- Watch product code IMC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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