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FDA 510(k)

T1040 AKA AURAWAVE

K-Number: K124055 · 2013-07-19

ApplicantEndurance Therapeutics
Decision Date2013-07-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

T1040 AKA AURAWAVE is the device name listed in this FDA 510(k) record. The listed applicant is Endurance Therapeutics. It received FDA 510(k) clearance on 2013-07-19 under 510(k) number K124055. 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 T1040 AKA AURAWAVE?

T1040 AKA AURAWAVE is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Endurance Therapeutics. The 510(k) number is K124055.

When did T1040 AKA AURAWAVE receive FDA 510(k) clearance?

T1040 AKA AURAWAVE received FDA 510(k) clearance on 2013-07-19, under 510(k) number K124055.

Who is the listed applicant for T1040 AKA AURAWAVE?

The FDA 510(k) record lists Endurance Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T1040 AKA AURAWAVE?

The FDA product code for T1040 AKA AURAWAVE is NUH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Endurance Therapeutics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060846THERAPEUTIC MASSAGE COMPANION

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.,LtdK260412TENS 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

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

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