510(k) K023050
- Device
- RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
- Applicant
- RELIANT TECHNOLOGIES, INC.
- 510(k) number
- K023050
- Product code
- IMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-14
- Date received
- 2002-09-13
- Regulation
- 890.5860
- Classification name
- Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNE WORDEN
- Address
- P.O. Box 405 Angels Camp CA US 95221 95221
FDA Registration Numbers#
- 1528161
- 3012316249
- 3017264244
- 3031944951
- 3038197172
- 2013558
- 3005170249
- 8040537
- 1054713
- 3012981024
- 8010720
- 1721293
- 3007535734
- 3030495752
- 2011115
- 1911273
- 9612147
- 3044563261
- 3010770433
- 9616086
- 3007502541
- 9617486
Source Documents#
Other 510(k) Records For Product Code IMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-10-07 |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | Accelerated Care Plus (Acp) | 2016-08-26 |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 |
| K150353 | BTL-4000 | BTL Industries, Inc. | 2015-11-13 |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 |
| K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | Zimmer Medizinsystems GmbH | 2012-08-07 |
| K102524 | FUTURA | Dr. Oliver Wenker, M.D., M.B.A. | 2011-11-03 |
| K111482 | SONICATOR PLUS 920 | Mettler Electronics Corp. | 2011-08-25 |
| K102190 | WINSTIM | Johari Digital Healthcare , Ltd. | 2011-03-17 |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Mettler Electronics Corp. | 2007-08-01 |
| K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Alfa Tech Medical Systems, Ltd. | 2007-04-04 |
| K063135 | SONIC-STIM | Naimco, Inc. | 2007-02-05 |
| K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM | Alfa Tech Medical Systems, Ltd. | 2005-12-09 |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | Chattanooga Group | 2004-04-12 |
Legacy Summary#
summary
FDA Review#
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