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FDA 510(k)

HBOTC Muscle and Nerve Stimulator

K-Number: K160255 · 2016-09-15

ApplicantHb Medical, Inc.
Decision Date2016-09-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HBOTC Muscle and Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Hb Medical, Inc.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160255. 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 HBOTC Muscle and Nerve Stimulator?

HBOTC Muscle and Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Hb Medical, Inc.. The 510(k) number is K160255.

When did HBOTC Muscle and Nerve Stimulator receive FDA 510(k) clearance?

HBOTC Muscle and Nerve Stimulator received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160255.

Who is the listed applicant for HBOTC Muscle and Nerve Stimulator?

The FDA 510(k) record lists Hb Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HBOTC Muscle and Nerve Stimulator?

The FDA product code for HBOTC Muscle and Nerve Stimulator is NUH.

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.

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.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS 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.

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