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FDA 510(k)

MODEL 1100 COLD THERAPY DEVICE

K-Number: K970533 · 1997-04-15

ApplicantSmith & Nephew, Inc.
Decision Date1997-04-15
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL 1100 COLD THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1997-04-15 under 510(k) number K970533. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1100 COLD THERAPY DEVICE?

MODEL 1100 COLD THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K970533.

When did MODEL 1100 COLD THERAPY DEVICE receive FDA 510(k) clearance?

MODEL 1100 COLD THERAPY DEVICE received FDA 510(k) clearance on 1997-04-15, under 510(k) number K970533.

Who is the listed applicant for MODEL 1100 COLD THERAPY DEVICE?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 1100 COLD THERAPY DEVICE?

The FDA product code for MODEL 1100 COLD THERAPY DEVICE is ILO.

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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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