Atlas FDA

RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI

FDA 510(k) clearance K023050 · decided 2003-02-14

Clearance details

K-number
K023050
Device name
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
Applicant
Reliant Technologies, Inc.
Decision
Substantially Equivalent
Date received
2002-09-13
Decision date
2003-02-14
Days to decision
154 days
Clearance type
Traditional
Product code
IMG
Device class
2
Regulation number
890.5860
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Angels Camp, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Reliant Technologies

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Ultrasound Therapy Workstation (XMS-UET2) (K244041)Xemis Medical Technology (Shenzhen) Co., Ltd.2025-10-07
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System (K153559)Accelerated Care Plus (Acp)2016-08-26
ComboRehab (K150436)Shenzhen Dongdixin Technology Co., Ltd.2015-11-13
BTL-4000 (K150353)BTL Industries, Inc.2015-11-13
SONICSTIMU COMBO THERAPEUTIC DEVICE (K120217)Shenzhen Dongdixin Technology Co., Ltd.2012-11-21
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (K121059)Zimmer Medizinsystems GmbH2012-08-07
FUTURA (K102524)Dr. Oliver Wenker, M.D., M.B.A.2011-11-03
SONICATOR PLUS 920 (K111482)Mettler Electronics Corp.2011-08-25
WINSTIM (K102190)Johari Digital Healthcare , Ltd.2011-03-17
CT2011 SONICSTIMU PAIN RELIEF DEVICE (K092627)Shenzhen Dongdixin Technology Co., Ltd.2010-01-14
SONICATOR PLUS 940, MODEL ME940 (K071137)Mettler Electronics Corp.2007-08-01
TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K063728)Alfa Tech Medical Systems, Ltd.2007-04-04

Recalls involving this device

No recalls on record reference this clearance.