IMA · Pack, Heat, Moist
Physical Medicine · 21 CFR 890.5730 · Class 1
Overview
| Product Code | IMA |
|---|---|
| Device Name | Pack, Heat, Moist |
| Regulation | 21 CFR 890.5730 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150139 | Rachel's Remedy | Rachel'S Remedies, LLC | May 22, 2015 | SESE |
| K950701 | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER | Wahl Clipper Corp. | Mar 24, 1995 | SESE |
| K841698 | HEAT PACK | Maddak, Inc. | May 10, 1984 | SESE |
| K832803 | STEAM PAK MOIST HEAT | Electro-Med Health Industries, Inc. | Sep 20, 1983 | SESE |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | Dec 30, 1982 | SESE |
| K803177 | MOIST HEAT PACK | Duro-Med Ind., Inc. | Dec 31, 1980 | SESE |
| K791653 | REUSABLE MOIST HEAT PACK | Tru-Eze Mfg. Co., Inc. | Sep 7, 1979 | SESE |
| K790904 | STAO-HOTPACK | Staodynamics, Inc. | May 18, 1979 | SESE |
Top Applicants
- Duro-Med Ind., Inc. — 1 clearance
- Electro-Med Health Industries, Inc. — 1 clearance
- Fred Sammons, Inc. — 1 clearance
- Maddak, Inc. — 1 clearance
- Rachel'S Remedies, LLC — 1 clearance
