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FDA 510(k)

5000Z SYSTEM (OTC)

K-Number: K033122 · 2004-08-25

ApplicantPrizm Medical, Inc.
Decision Date2004-08-25
Product CodeNUH
Advisory CommitteeNE
DecisionUnknown

Device Summary

5000Z SYSTEM (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Prizm Medical, Inc.. It received FDA 510(k) clearance on 2004-08-25 under 510(k) number K033122. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the 5000Z SYSTEM (OTC)?

5000Z SYSTEM (OTC) is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is Prizm Medical, Inc.. The 510(k) number is K033122.

When did 5000Z SYSTEM (OTC) receive FDA 510(k) clearance?

5000Z SYSTEM (OTC) received FDA 510(k) clearance on 2004-08-25, under 510(k) number K033122.

Who is the listed applicant for 5000Z SYSTEM (OTC)?

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

What is the FDA product code for 5000Z SYSTEM (OTC)?

The FDA product code for 5000Z SYSTEM (OTC) is NUH.

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Other records listing Prizm Medical, 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.

K032239THERA-CREAM, MODEL TCT004K024181PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEMK012974PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007K951727Z-WATCH SYSTEMK944487ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODESK932299ELECTRO-MESH

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

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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