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FDA 510(k)

EMPI TAPE PATCHES

K-Number: K941389 · 1994-08-23

ApplicantEmpi
Decision Date1994-08-23
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMPI TAPE PATCHES is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1994-08-23 under 510(k) number K941389. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPI TAPE PATCHES?

EMPI TAPE PATCHES is a medical device that received FDA 510(k) clearance on 1994-08-23. The listed applicant is Empi. The 510(k) number is K941389.

When did EMPI TAPE PATCHES receive FDA 510(k) clearance?

EMPI TAPE PATCHES received FDA 510(k) clearance on 1994-08-23, under 510(k) number K941389.

Who is the listed applicant for EMPI TAPE PATCHES?

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

What is the FDA product code for EMPI TAPE PATCHES?

The FDA product code for EMPI TAPE PATCHES is KGX.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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