Halter, Head, Traction
A head halter for traction is an orthopedic device worn on the head and chin to apply cervical traction, used to reduce neck pain and treat conditions such as cervical disc herniation, nerve root compression, or muscle spasm. It is classified as an FDA Class 1 device under 21 CFR 888.5890, indicating minimal risk subject to general controls. Product code HSS falls under the Orthopedic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HSS
- Device Class
- FDA class 1
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K771109 | ORTHOPEDIC SOFT GOODS | Jun 27, 1977 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K770910 | MEDISHIELD CERVICAL COLLAR | May 25, 1977 | Substantially Equivalent | Fraser Sweatman, Inc. |
| K760869 | SPLIT CERVICAL COLLAR/HEAD HALTER | Nov 01, 1976 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.