510(k) K131899
- Device
- SW-THERM
- Applicant
- SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
- 510(k) number
- K131899
- Product code
- IMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-14
- Date received
- 2013-06-25
- Regulation
- 890.5290
- Classification name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JIANPING KANG
- Address
- # 3 Bldg. Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen CN 518108 518108
FDA Registration Numbers#
- 3007134923
- 1412854
- 3004154499
- 3005170249
- 9616086
- 3012316249
- 3013682776
- 3017264244
- 9612147
- 2011115
- 1911273
- 2013558
- 8010720
- 3014122529
- 2032108
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IMJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250376 | ViVY | Viatherm Therapeutics, LLC | 2025-11-05 |
| K243112 | Curapuls 670 | Enraf-Nonius, B.V. | 2025-06-25 |
| K223620 | Reprieve by RegenesisTM | Regenesis Biomedical, Inc. | 2023-05-24 |
| K182363 | BTL-703 | BTL Industries, Inc. | 2019-01-24 |
| K173300 | ViaTherm BOOST | Viatherm Therapeutics, LLC | 2018-05-01 |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Promedtek, Inc. | 2016-11-17 |
| K161862 | ThermoPro | Zimmer Medizinsysteme GmbH | 2016-11-14 |
| K153456 | Megapulse III Shortwave Diathermy | Accelerated Care Plus | 2016-06-14 |
| K131926 | THERMOPULSE | Ibramed Equipamentos Medicos | 2014-07-24 |
| K121123 | BIOFUSIONARY BEBE | Rocky Mountain Biosystems, Inc. | 2014-03-10 |
| K120093 | BTL ELITE | BTL Industries, Inc. | 2012-10-05 |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | Chattanooga Group | 2009-03-18 |
| K042554 | AUTO THERM 390, MODEL ME 390 | Mettler Electronics Corp. | 2004-10-08 |
| K030382 | SELITHERM, MODEL C100 | Selicor, Inc. | 2003-04-01 |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Ito Co., Ltd. | 2003-01-28 |
Legacy Summary#
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FDA Review#
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