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FDA 510(k)

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical

K-Number: K222988 · 2023-09-01

ApplicantHt Medical D.B.A. Xenix Medical
Decision Date2023-09-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is a medical device manufactured by Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2023-09-01 under approval number K222988. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical?

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Ht Medical D.B.A. Xenix Medical. The 510(k) number is K222988.

When was neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical approved by the FDA?

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical received FDA 510(k) clearance on 2023-09-01, under approval number K222988.

What company makes neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical?

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is manufactured by Ht Medical D.B.A. Xenix Medical.

What is the FDA product code for neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical?

The FDA product code for neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is ODP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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