Product code IMA
- Device name
- Pack, Heat, Moist
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5730
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150139 | Rachel's Remedy | Rachel'S Remedies, LLC | 2015-05-22 |
| K950701 | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER | Wahl Clipper Corp. | 1995-03-24 |
| K841698 | HEAT PACK | Maddak, Inc. | 1984-05-10 |
| K832803 | STEAM PAK MOIST HEAT | Electro-Med Health Industries, Inc. | 1983-09-20 |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | 1982-12-30 |
| K803177 | MOIST HEAT PACK | Duro-Med Ind., Inc. | 1980-12-31 |
| K791653 | REUSABLE MOIST HEAT PACK | Tru-Eze Mfg. Co., Inc. | 1979-09-07 |
| K790904 | STAO-HOTPACK | Staodynamics, Inc. | 1979-05-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16901452000178 | Hwato Stick-on Moxa | Suzhou Medical Appliance Factory | 2023-11-15 |
| 00057475570446 | BIOS Living | Thermor Ltd | 2023-03-31 |
| 08800018916544 | GuGwan Moxa Smokeless | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 28800018916432 | CHARCOAL SMOKELESS MOXA CONES | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916565 | Gold Moxa | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916558 | GuGwan Moxa | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916541 | GuGwan Moxa Smokeless | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916534 | Smokeless Mini Moxa | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916510 | """Moxa Shield """ | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916459 | GuGwan Burning Bowl 5Holes | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916435 | CHARCOAL SMOKELESS MOXA CONES | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916428 | Tiger Warmer Large | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916411 | Tiger Warmer Small | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018914561 | DBC Moxa Burner | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 08800018916568 | Gold Moxa | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 08800018916551 | GuGwan Moxa | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 08800018916537 | Smokeless Mini Moxa | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 18800018916442 | GuGwan Burning Bowl 1Hole | Dong Bang Medical co.,Ltd. | 2023-01-15 |
| 00810084936887 | FifthPulse | Jeg & Sons Inc. | 2022-12-16 |
| 00810084936894 | FifthPulse | Jeg & Sons Inc. | 2022-12-16 |
| 04979844552005 | CHOSEI-KYU MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04979844532007 | CHOSEI-KYU MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04979844522008 | CHOSEI-KYU MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04979844431003 | CHOSEI-KYU MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04979844402034 | CHOSEI-KYU MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04979844145009 | GOLD MOUNTAIN MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04979844113008 | FUKUJU MOXA | YAMASHO CO.,LTD. | 2022-11-30 |
| 04547248831035 | SEIRIN MOXSAFE | SEIRIN CORPORATION | 2018-05-24 |
| 04547248831028 | SEIRIN MOXSAFE | SEIRIN CORPORATION | 2018-05-24 |
| 04547248831011 | SEIRIN MOXSAFE | SEIRIN CORPORATION | 2018-05-24 |