Upper Body Exerciser
by Henley Intl.
510(k) K926279
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926279 | Date5 May 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ISD
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5360
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Upper Body Exerciser is an exerciser, measuring device, classified under the medical specialty of Physical Medicine. It is designed to provide exercise for the upper body.
The Upper Body Exerciser is supplied with FDA 510K authorizations, specifically with the clearance type Traditional and the decision description Substantially Equivalent. The device has a product code of ISD and a regulation number of 890.5360, with the review advisory committee being PM. The device is manufactured by Henley Intl. and has a k number of K926279.
Other devices from Henley Intl.
Questions
AI-generated answers, 28 Sep 2026
What is the Upper Body Exerciser used for?
The Upper Body Exerciser is designed to provide exercise for the upper body, helping to improve strength and mobility.
Is the Upper Body Exerciser a single-use or reusable device?
The device data does not specify whether the Upper Body Exerciser is single-use or reusable, it is recommended to consult the manufacturer's instructions for guidance.
What regulatory authorizations does the Upper Body Exerciser have?
The Upper Body Exerciser has FDA 510K authorizations, specifically with the clearance type Traditional and the decision description Substantially Equivalent.