510(k) K042057
- Device
- INFINITY ELECTROTHERAPY SYSTEM
- Applicant
- EMPI
- 510(k) number
- K042057
- Product code
- LIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-17
- Date received
- 2004-07-30
- Regulation
- 882.5890
- Classification name
- Interferential Current Therapy
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY MCNAMARA-CULLINANE
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3006850006
- 3017866822
- 2031823
- 2013558
- 1721293
- 3012316249
- 2024292
- 3038197172
- 3012251759
- 3013069546
- 1644243
- 3017936974
- 3014314933
- 3017264244
- 9616086
- 3006621944
- 3027241812
- 1528161
- 3010805941
- 3010405397
- 9710582
- 3007502541
- 8010720
- 3005170249
- 3014315574
- 3008525454
- 3010362721
- 3030151584
- 3004753827
- 9615033
- 2032724
- 3005463575
- 3004049909
- 3003573572
- 3006153348
- 3004558433
- 3010280625
- 3013917867
- 3005095860
- 8022189
- 2954348
- 3004146401
- 2510425
- 8040537
Source Documents#
Other 510(k) Records For Product Code LIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231575 | Vecttor VT-300 | Artaflex, Inc. | 2024-02-08 |
| K202725 | ETD4000 | Therasigma, LLC | 2021-03-26 |
| K183692 | Avid IF2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2019-06-12 |
| K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | Gemore Technology Co, Ltd. | 2012-12-21 |
| K121662 | VECTTOR VT-200 | Alan Neuromedical Technologies, LLC | 2012-11-21 |
| K110509 | EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 | Everyway Medical Instruments Co.,Ltd | 2011-06-20 |
| K100246 | MAX-IF1000 | Bio Protech, Inc. | 2010-11-24 |
| K092780 | INF 4160 PLUS, MODEL D-FJ31F | Fuji Dynamics Limited | 2010-01-07 |
| K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D | Well-Life Healthcare Limited | 2009-10-08 |
| K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E | Well-Life Healthcare Limited | 2009-01-30 |
| K070890 | EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 | Everlife Medical Equipment Co., Ltd. | 2007-06-29 |
| K060975 | IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 | Theratech, Inc. | 2006-05-10 |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | Biowave Corporation | 2005-12-13 |
| K043407 | INF 4160, MODEL D-FJ27F | Fuji Dynamics Limited | 2005-02-11 |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | Biomedical Life Systems, Inc. | 2004-07-07 |
Legacy Summary#
summary
FDA Review#
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