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FDA 510(k)

HEEL LOOPS

K-Number: K780193 · 1978-02-14

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1978-02-14
Product CodeKNO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEEL LOOPS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1978-02-14 under 510(k) number K780193. The device is classified under product code KNO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEEL LOOPS?

HEEL LOOPS is a medical device that received FDA 510(k) clearance on 1978-02-14. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K780193.

When did HEEL LOOPS receive FDA 510(k) clearance?

HEEL LOOPS received FDA 510(k) clearance on 1978-02-14, under 510(k) number K780193.

Who is the listed applicant for HEEL LOOPS?

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

What is the FDA product code for HEEL LOOPS?

The FDA product code for HEEL LOOPS is KNO.

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Other records listing Orthopedic Equipment Co., 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.

K834035UNIVERSAL SELF-ALIGNING ACETABULAR COMK841189OEC/REZAIAN SPINAL FIXATORK800530SCHLEIN TRI-SURFACE ANKLEK781445SPREADERK790247TOURNIQUET TEST GAGEK790209FILTER SYSTEM, ALTNER DISPOSABLE

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Related Devices (Code: KNO)

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.

K870298REDMAN ACCESSORIESRedman, Inc.K823646FRICTION FEEDERFred Sammons, Inc.K823645VELCRO STRAPS TO HOLD ARM TO WHEELCHAIRFred Sammons, Inc.K823816WHEELCHAIR PATIENT RESTRAINTSDanek Medical, Inc.K823635CUSHIONS FOR WHEELCHAIR ARMSFred Sammons, Inc.K823636ARM THROUGH FOR WHEELCHAIR BK-6459-01 &Fred Sammons, 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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