Chin Up
FDA 510(k) K943837 · Edward Carden
510(k) numberK943837
Submission
- Device name
- Chin Up
- Applicant
- Edward Carden
Marina Del Rey, CA, US - Received
- August 5, 1994
- Decision date
- October 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCX – Support, Patient Position
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6820
- Specialty
- Anesthesiology
Other 510(k)s with product code CCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932305 | Vila-Cooke(Tm) Anesthesia PillowCCX · Traditional | Sharn, Inc. | 10/05/1993SE |
| K934235 | Sniff Position PillowCCX · Traditional | American Medical Development, Inc. | 10/01/1993SE |
| K861915 | Surgical Head SupportCCX · Traditional | Treace Medical, Inc. | 05/30/1986SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | Scientific Sales Intl., Inc. | 10/14/1983SE |
| K821838 | Vari-Support Low Back Posture PillowCCX · Traditional | Body Therapeutics, Inc. | 07/20/1982SE |
| K810035 | Prenatal Support PillowCCX · Traditional | Supportech, Inc. | 01/23/1981SE |
| K801330 | Anspach Leg SupportCCX · Traditional | The Anspach Effort, Inc. | 06/26/1980SE |
Questions and answers
When was Chin Up cleared by the FDA?
Chin Up (K943837) received a 510(k) decision of Substantially Equivalent on October 14, 1994, 70 days after the submission was received.
What is the product code of K943837?
The FDA product code is CCX – Support, Patient Position, a Class I (low risk) device regulated under 21 CFR 868.6820.