510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881284Substantially Equivalent

Computerized Orthopaedic Pedotopography Machine

Nathaniel Gould Diagnostics, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881284 is the FDA 510(k) clearance record for COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE, a class I device, cleared for Nathaniel Gould Diagnostics, Inc. on under FDA product code JFC (System, Pressure Measurement, Intermittent). FDA records list one 510(k) clearance for Nathaniel Gould Diagnostics, Inc. As of , FDA records show no recalls naming K881284.

Clearance record

Decision date
Received
(118 days to decision)
Product code
JFC System, Pressure Measurement, Intermittent
Regulation
21 CFR 890.1600
Device class
Class I
Review panel
Physical Medicine
Applicant
Nathaniel Gould Diagnostics, Inc. 121 N. Plains Industrial Rd., Wallingford CT
Third party review
No

Clearances, product code JFC

Trailing 12 months

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

FDA records show no clearances under product code JFC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JFC, 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