510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872548Substantially Equivalent

Fitness Recumbent Ergometer, Model Ft1400

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872548 is the FDA 510(k) clearance record for FITNESS RECUMBENT ERGOMETER, MODEL FT1400, a class II device, cleared for Invacare Corp. on under FDA product code DPS (Electrocardiograph). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K872548.

Clearance record

Decision date
Received
(169 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Invacare Corp. 899 Cleveland St., Elyria OH
Third party review
No

Clearances, product code DPS

Trailing 12 months
7 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20261