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FDA 510(k)

PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER

K-Number: K122744 · 2013-03-28

ApplicantProspera Corporation
Decision Date2013-03-28
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Prospera Corporation. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K122744. 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 PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER?

PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Prospera Corporation. The 510(k) number is K122744.

When did PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER receive FDA 510(k) clearance?

PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER received FDA 510(k) clearance on 2013-03-28, under 510(k) number K122744.

Who is the listed applicant for PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER?

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

What is the FDA product code for PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER?

The FDA product code for PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER is NUH.

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Other records listing Prospera Corporation 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.

K113544ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER

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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