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FDA 510(k)

EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)

K-Number: K851331 · 1985-07-17

ApplicantEmpi
Decision Date1985-07-17
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1985-07-17 under 510(k) number K851331. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)?

EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) is a medical device that received FDA 510(k) clearance on 1985-07-17. The listed applicant is Empi. The 510(k) number is K851331.

When did EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) receive FDA 510(k) clearance?

EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) received FDA 510(k) clearance on 1985-07-17, under 510(k) number K851331.

Who is the listed applicant for EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)?

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 MODEL 100, CPM(POWER EXCERISE EQUIPMENT)?

The FDA product code for EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) is BXB.

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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: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.

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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