P-POD DD-1930

GUDID 00196852667895

P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner.

PPOD Orthotics Inc.

Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis

• Primary Device ID: 00196852667895
• NIH Device Record Key: f9dccef2-de8a-42e6-812e-12537c4ee0a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-POD
• Version Model Number: DD-1930
• Catalog Number: DD-1930
• Company DUNS: 119136241
• Company Name: PPOD Orthotics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com
• Phone: 1 (607) 744-3321
• Email: kkellam@ppodpediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852667895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133397

FDA Product Code

• MVA: Orthosis, Cranial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-28
• Device Publish Date: 2023-11-20