Isorobic Skinfold Caliper
FDA 510(k) K810116 · Fitness Motivation Institute of America
510(k) numberK810116
Submission
- Device name
- Isorobic Skinfold Caliper
- Applicant
- Fitness Motivation Institute of America
Mchenry, IL, US - Received
- January 15, 1981
- Decision date
- February 4, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTZ – Caliper
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4150
- Specialty
- Orthopedic
Other 510(k)s with product code KTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921266 | NK Medical Micrometer, Model MC001KTZ · Traditional | Nk Biotechnical Engineering Co. | 07/14/1992SE |
| K841687 | Skyndex Electronic Body Fat CalculaKTZ · Traditional | Caldwell, Justiss & Co., Inc. | 06/28/1984SE |
| K831898 | ScolimeterKTZ · Traditional | Dr. Micheal A. Sabia | 07/19/1983SE |
| K820659 | A CaliperKTZ · Traditional | Twin City Surgical, Inc. | 03/19/1982SE |
| K800363 | Parke-Davis Total Knee ProsthesisKTZ · Traditional | Warner-Lambert Co. | 03/10/1980SE |
| K760521 | Tape MeasureKTZ · Traditional | Mcgaw Laboratories | 11/12/1976SE |
Questions and answers
When was Isorobic Skinfold Caliper cleared by the FDA?
Isorobic Skinfold Caliper (K810116) received a 510(k) decision of Substantially Equivalent on February 4, 1981, 20 days after the submission was received.
What is the product code of K810116?
The FDA product code is KTZ – Caliper, a Class I (low risk) device regulated under 21 CFR 888.4150.