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FDA 510(k)

PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE

K-Number: K901796 · 1990-06-06

ApplicantComponent Equipment Mfg., Inc.
Decision Date1990-06-06
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE is the device name listed in this FDA 510(k) record. The listed applicant is Component Equipment Mfg., Inc.. It received FDA 510(k) clearance on 1990-06-06 under 510(k) number K901796. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE?

PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE is a medical device that received FDA 510(k) clearance on 1990-06-06. The listed applicant is Component Equipment Mfg., Inc.. The 510(k) number is K901796.

When did PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE receive FDA 510(k) clearance?

PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE received FDA 510(k) clearance on 1990-06-06, under 510(k) number K901796.

Who is the listed applicant for PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE?

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

What is the FDA product code for PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE?

The FDA product code for PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE is ISA.

Related Clinical Trials

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.

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Other records listing Component Equipment Mfg., 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.

K881603ULTRA TRACTION

Related Devices (Code: ISA)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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