Product Code: HSQ FDA class 1 21 CFR 888.5890

Belt, Pelvic, Traction

Orthopedic

A pelvic traction belt is an orthopedic device applied around the pelvis to provide traction to the lumbar spine and pelvis, used in the management of lower back pain and certain spinal conditions. It is classified as an FDA Class 1 device under 21 CFR 888.5890, indicating minimal risk subject to general controls. Product code HSQ falls under the Orthopedic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

510(k)s
1
FEI Numbers
26
Registration Numbers
26
Unique Applicants
1
Years Active

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Basic Information

Product Code
HSQ
Device Class
FDA class 1
Regulation Number
888.5890
Medical Specialty
Orthopedic
Review Panel
OR
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K761036 WILSON SPINAL FRAME

FEI Numbers

This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.