510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K970543Substantially Equivalent

Bobcat Dx

Quest Enabling Designs, Ltd., Fareham, Hampshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970543 is the FDA 510(k) clearance record for BOBCAT DX, a class II device, cleared for Quest Enabling Designs , Ltd. on under FDA product code IPL (Wheelchair, Standup). FDA records list one 510(k) clearance for Quest Enabling Designs , Ltd. As of , FDA records show no recalls naming K970543.

Clearance record

Decision date
Received
(134 days to decision)
Product code
IPL Wheelchair, Standup
Regulation
21 CFR 890.3900
Device class
Class II
Review panel
Physical Medicine
Applicant
Quest Enabling Designs , Ltd. Ability House, 242 Gosport Rd., Fareham, Hampshire, GB
510(k) summary
Summary
Third party review
No

Clearances, product code IPL

Trailing 12 months

FDA records hold no clearances under product code IPL in the trailing twelve months.

FDA records show no clearances under product code IPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260