C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570— 510(k) K000354

Name: FDA 510(k) clearance K000354
Creator: U.S. Food and Drug Administration
Published: 2000-08-25

Substantially Equivalent

Warepalmy Enterprise, LLC (Usa)

FDA 510(k) clearance K000354 for C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570, Substantially Equivalent on 2000-08-25. Applicant: Warepalmy Enterprise, LLC (Usa). Device class: 2.

Clearance details

Applicant: Warepalmy Enterprise, LLC (Usa)
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2000-02-04
Decision date: 2000-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Warepalmy Enterprise, LLC (Usa)

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K012791 — C.T.M. MOBILITY SCOOTER MODEL # HS-3202001-10-24
K012792 — C.T.M. MOBITIY SCOOTER MODEL #HS-3602001-10-24
K002983 — C.T.M. POWER CHAIR, MODEL HS-56002000-10-11
K000356 — C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-5802000-08-25
K983662 — C.T.M. MOBILITY SCOOTER, MODEL # HS-6861998-12-18

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.