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FDA 510(k)

HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809

K-Number: K101614 · 2011-01-13

ApplicantDm Systems, Incorporated
Decision Date2011-01-13
Product CodeDWL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 is the device name listed in this FDA 510(k) record. The listed applicant is Dm Systems, Incorporated. It received FDA 510(k) clearance on 2011-01-13 under 510(k) number K101614. The device is classified under product code DWL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809?

HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 is a medical device that received FDA 510(k) clearance on 2011-01-13. The listed applicant is Dm Systems, Incorporated. The 510(k) number is K101614.

When did HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 receive FDA 510(k) clearance?

HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 received FDA 510(k) clearance on 2011-01-13, under 510(k) number K101614.

Who is the listed applicant for HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809?

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

What is the FDA product code for HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809?

The FDA product code for HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 is DWL.

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Related Devices (Code: DWL)

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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