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510(k) K133397

P-POD by P-Pod — Product Code MVA

K133397 is an FDA 510(k) premarket notification submitted by P-Pod for the device "P-POD". The FDA issued a decision of Substantially Equivalent on April 18, 2014. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2014
Date Received
November 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cranial
Device Class
Class II
Regulation Number
882.5970
Review Panel
NE
Submission Type

Other clearances for product code MVA

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  • K223238 — STARband 3D (April 20, 2023)
  • K220681 — Talee, Talee PostOP (September 22, 2022)
  • K203134 — Hanger Cranial Band 3D (July 1, 2022)
  • K213587 — MyCRO Band (June 9, 2022)
  • K193383 — SnugKap (June 7, 2021)
  • K201426 — MyCRO Band (March 26, 2021)
  • K180568 — KidCap (October 16, 2018)
  • K141842 — STARBAND, STARLIGHT (October 6, 2014)

FDA data resources