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FDA 510(k)

HI-DOW-XP

K-Number: K102598 · 2011-05-13

ApplicantHi-Dow International, Inc.
Decision Date2011-05-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HI-DOW-XP is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K102598. 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 HI-DOW-XP?

HI-DOW-XP is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K102598.

When did HI-DOW-XP receive FDA 510(k) clearance?

HI-DOW-XP received FDA 510(k) clearance on 2011-05-13, under 510(k) number K102598.

Who is the listed applicant for HI-DOW-XP?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-DOW-XP?

The FDA product code for HI-DOW-XP is NUH.

Other records listing Hi-Dow International, Inc. 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.

K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)K210383Wrap Accessory ElectrodesK202337Pulsed electromagnetic field wrapK190617Wrap accessory electrodesK163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)

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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