Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PlayMakar Sport Muscle Stimulator, Model PRO-500

K-Number: K182581 · 2018-11-21

ApplicantPlaymakar, Inc.
Decision Date2018-11-21
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PlayMakar Sport Muscle Stimulator, Model PRO-500 is the device name listed in this FDA 510(k) record. The listed applicant is Playmakar, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182581. 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 PlayMakar Sport Muscle Stimulator, Model PRO-500?

PlayMakar Sport Muscle Stimulator, Model PRO-500 is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Playmakar, Inc.. The 510(k) number is K182581.

When did PlayMakar Sport Muscle Stimulator, Model PRO-500 receive FDA 510(k) clearance?

PlayMakar Sport Muscle Stimulator, Model PRO-500 received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182581.

Who is the listed applicant for PlayMakar Sport Muscle Stimulator, Model PRO-500?

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

What is the FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500?

The FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500 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.

↑