iBOT® PMD— 510(k) K243442
Substantially EquivalentMobius Mobility
FDA 510(k) clearance K243442 for iBOT® PMD, Substantially Equivalent on 2025-01-30. Applicant: Mobius Mobility. Device class: 2.
Clearance details
- Applicant
- Mobius Mobility
- Product code
- Code IMK
- Device class
- Class 2
- Regulation
- 21 CFR 890.3890
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manchester, NH, US
Recent devices under product code IMK
view allRecalls naming K243442
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243442.
Data sourced from openFDA. This site is unofficial and independent of the FDA.