FDA product code HSS: Halter, Head, Traction
HSS is the FDA product code for halter, head, traction. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under HSS, from 3 different applicants. The average 510(k) review took 9 days (median 7).
Classification
| Field | Value |
|---|---|
| Device name | Halter, Head, Traction |
| Device class | Class I |
| Regulation | 21 CFR 888.5890 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HSS clearance
Top HSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 1 | 1977-06-27 |
| Fraser Sweatman, Inc. | 1 | 1977-05-25 |
| Orthopedic Equipment Co., Inc. | 1 | 1976-11-01 |
Most recent HSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771109 | Orthopedic Systems, Inc. | ORTHOPEDIC SOFT GOODS | 1977-06-27 | 7 |
| K770910 | Fraser Sweatman, Inc. | MEDISHIELD CERVICAL COLLAR | 1977-05-25 | 6 |
| K760869 | Orthopedic Equipment Co., Inc. | SPLIT CERVICAL COLLAR/HEAD HALTER | 1976-11-01 | 14 |
Recalls for HSS devices
openFDA lists no recalls for product code HSS.
Frequently asked questions
What is FDA product code HSS?
HSS is the FDA product code for halter, head, traction. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Physical Medicine panel.
What device class is HSS?
Class I, regulation 21 CFR 888.5890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HSS?
Across 3 cleared submissions the average was 9 days from receipt to decision (median 7).
Which companies have the most HSS clearances?
Orthopedic Systems, Inc. (1); Fraser Sweatman, Inc. (1); Orthopedic Equipment Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HSS
- Run a recall and safety report across every HSS manufacturer
- Watch product code HSS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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