FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D

K Number: K092763 · Decision Oct 8, 2009
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
22
Review Days
29

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Basic Information

Device Name
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K Number
K092763
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Well-Life Healthcare Limited
Date Received
September 9, 2009
Decision Date
October 8, 2009
Product Code
LIH
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LIH Interferential Current Therapy

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Other Clearances by Well-Life Healthcare Limited

K Number Device Name
K233054 Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
K222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
K220524 Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K213091 Well-Life TENS/EMS/Heating Stimulator
K200942 Well-Life Garment Electrodes (GM Series)
K172809 OTC Combo TENS/EMS System
K162663 WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
K161453 WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K141299 OTC COMBO TENS/EMS SYSTEM
K133723 OTC PATCH
Search all 22 clearances from Well-Life Healthcare Limited →