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FDA 510(k)

SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE

K-Number: K981885 · 1998-11-12

ApplicantSunrise Medical, Inc.
Decision Date1998-11-12
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical, Inc.. It received FDA 510(k) clearance on 1998-11-12 under 510(k) number K981885. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE?

SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is Sunrise Medical, Inc.. The 510(k) number is K981885.

When did SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE receive FDA 510(k) clearance?

SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE received FDA 510(k) clearance on 1998-11-12, under 510(k) number K981885.

Who is the listed applicant for SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE?

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

What is the FDA product code for SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE?

The FDA product code for SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE is INI.

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Official Source

View on FDA Database →

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