FDA 510(k)

OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407

K-Number: K063660 · 2007-02-07

Decision Date2007-02-07

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2007-02-07 under 510(k) number K063660. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407?

OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 is a medical device that received FDA 510(k) clearance on 2007-02-07. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K063660.

When did OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 receive FDA 510(k) clearance?

OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 received FDA 510(k) clearance on 2007-02-07, under 510(k) number K063660.

Who is the listed applicant for OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407?

The FDA product code for OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 is NUH.

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Other records listing Well-Life Healthcare Limited as applicant

K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)K213091Well-Life TENS/EMS/Heating Stimulator K200942Well-Life Garment Electrodes (GM Series)K172809OTC Combo TENS/EMS System

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Related Devices (Code: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K251958VEINOPLUS BackDynapulse Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.