Companies / Precision Medical Products

Medical device company profile

Precision Medical Products

Branded DVT-prevention and recovery products supported by patient delivery and service operations.

Medical Device ManufacturerCardiovascular & VascularOrthopedics & MusculoskeletalVenous ThromboembolismRehabilitation & RecoveryCommercial-stage

Headquarters🇺🇸United States

FoundedNot confirmed

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitepmpmed.com ↗

Company overview

Precision Medical Products offers prevention and recovery products, including Circul8 Pro portable compression for DVT prevention. Its operating model includes product delivery, patient support and durable-medical-equipment services alongside its branded portfolio.

The matched FDA Circul8 Pro and Circul8 Luxe decisions name Ortho8, Inc. as applicant. The profile retains that legal applicant rather than attributing those clearances directly to PMP. An older Circul8 Luxe recall remains open in the reviewed FDA record; its later clearance does not itself terminate the recall.

This profile covers PMP’s own branded prevention and recovery offering. Current headquarters and chief-executive identity require further reconciliation: company material includes a California address and an earlier Texas relocation announcement, so neither is presented as settled current headquarters.

^[14][15][16]

Products & regulatory status How does MedTechIndex get this information?

Summary

Circul8 Pro’s authorizations and current commercial role are distinct from the legacy Circul8 Luxe/EVEXIA Luxe recall. Other Ortho8 products and similarly named needle manufacturers are not automatically part of the current Precision portfolio. ^{[14][16][2][3][1]}

The matched FDA history contains 1 distinct recall event: 1 open, 0 terminated. Z-2324-2021 (2021-07-09; open, classified): CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance ^[10][11]

Regulatory snapshot How to read this snapshot

U.S. FDA

1
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

View 1 documented open recall event

Includes open events outside the mapped current portfolio; those events are excluded from the snapshot count.

Documented open FDA recall events
Recalled product / record	Initiated	Source
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein ThrombosisZ-2324-2021	July 9, 2021	^[10][19]

Commercial portfolio snapshot

Documented commercial product families.

Portable pneumatic compression

Circul8 Pro ↗

Portable compression device offered through PMP for DVT prevention. ^[16][18]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Products with unconfirmed commercial availability

Portable pneumatic compression

Circul8 Luxe — legacy record ↗

Legacy model retained to show the matched authorization and historical recall. ^[14][17]

Commercial availability not established

Current availability not established.

Commercial development

Current Pro offering separated from legacy Luxe regulatory history. Headquarters and current CEO remain unresolved. ^[14][16]

19 Cited Sources

Accessed 10/20/2026

[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[2] FDA K193020 — VenaPro Vascular Therapy System ↗U.S. Food and Drug Administration · regulatory record

[3] FDA K200285 — VenaOne ↗U.S. Food and Drug Administration · regulatory record

[4] FDA K211235 — CIRCUL8 Luxe DVT Prevention Device ↗U.S. Food and Drug Administration · regulatory record

[5] FDA K212731 — Circul8 Pro ↗U.S. Food and Drug Administration · regulatory record

[6] FDA K220761 — CIRCUL8 Connect DVT Prevention Device ↗U.S. Food and Drug Administration · regulatory record

[7] FDA De Novo database — research search ↗FDA / openFDA · regulatory record

[8] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[9] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[10] FDA recall Z-2324-2021 — Ortho8, Inc. ↗U.S. Food and Drug Administration · regulatory record

[11] FDA recall Z-2325-2021 — Ortho8, Inc. ↗U.S. Food and Drug Administration · regulatory record

[12] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[13] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[14] Company and branded product scope ↗Precision Medical Products · company website

[15] Employer hiring source reviewed ↗Precision Medical Products · company website

[16] Circul8 Pro product ↗Precision Medical Products · company website

[17] FDA 510(k) K211235 ↗U.S. Food and Drug Administration · regulatory database

[18] FDA 510(k) K212731 ↗U.S. Food and Drug Administration · regulatory database

[19] FDA recall Z-2324-2021 ↗U.S. Food and Drug Administration · regulatory database