PARA THERM BATH
FDA 510(k) clearance K842423 · decided 1984-06-28
Clearance details
- K-number
- K842423
- Device name
- PARA THERM BATH
- Applicant
- Grimm Scientific Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-20
- Decision date
- 1984-06-28
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- IMC
- Device class
- 2
- Regulation number
- 890.5110
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| THERMAMED BATH (K833631) | Bernlit Enterprises, Inc. | 1983-11-28 |
| MADDATHERM PARAFFIN BATH (K770170) | Techhnilab Instruments, Inc. | 1977-01-28 |
Recalls involving this device
No recalls on record reference this clearance.