Gladiator Antishock Pants
FDA 510(k) K953763 · Jobst Institute, Inc.
510(k) numberK953763
Submission
- Device name
- Gladiator Antishock Pants
- Applicant
- Jobst Institute, Inc.
Charlotte, NC, US - Received
- August 11, 1995
- Decision date
- November 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHX – Trousers, Anti-Shock
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code LHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874774 | Trousers, Pneumatic, Anti-Shock Three BladdersLHX · Traditional | Vinyl Technology, Inc. | 02/08/1988SE |
| K841605 | BP Trauma Air PantsLHX · Traditional | Bp Medical Systems, Inc. | 07/06/1984SE |
| K812564 | Zee Life Support Air PantsLHX · Traditional | Zee Medical Products Co., Inc. | 10/23/1981SE |
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Questions and answers
When was Gladiator Antishock Pants cleared by the FDA?
Gladiator Antishock Pants (K953763) received a 510(k) decision of Substantially Equivalent on November 28, 1995, 109 days after the submission was received.
What is the product code of K953763?
The FDA product code is LHX – Trousers, Anti-Shock, a Class II (moderate risk) device regulated under 21 CFR 870.5800.