First MPJ Continuous Passive Motion Device
FDA 510(k) K926262 · Sgarlato Laboratories, Inc.
510(k) numberK926262
Submission
- Device name
- First MPJ Continuous Passive Motion Device
- Applicant
- Sgarlato Laboratories, Inc.
San Jose, CA, US - Received
- December 18, 1992
- Decision date
- January 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BXB – Exerciser, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5380
- Specialty
- Physical Medicine
Other 510(k)s with product code BXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072887 | G-Trainer MedicalBXB · Traditional | Alter-G, Inc. | 01/25/2008SE |
| K003272 | Flo-BootBXB · Traditional | Discovery Group, LLC | 04/04/2001SE |
| K952975 | Ankle Calf Exerciser PhlebopumpBXB · Traditional | Prevent Products, Inc. | 09/25/1996SE |
| K953456 | E-Z FlexBXB · Traditional | Fluid Motion Biotechnologies, Inc. | 01/26/1996SE |
| K955106 | Bte CPM-20BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K955105 | Bte CPM-10BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K951028 | Hamex TwoBXB · Traditional | Northern Orthopaedic Products, Inc. | 12/11/1995SE |
| K950755 | Flexmate K500BXB · Traditional | Breg, Inc. | 10/05/1995SE |
| K951029 | Hamex OneBXB · Traditional | Northern Orthopaedic Products, Inc. | 09/15/1995SE |
| K945733 | Aquahab, Model 120-72-101BXB · Traditional | Aquarius Electronics, Inc. | 09/15/1995SE |
More from Aquarius Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043204 | Sgarlato Labs Painfree Pump and Pain Control Infusion PumpFRN · Traditional | 03/30/2005SE |
| K990101 | Pain Control Infusion PumpFRN · Traditional | 03/19/1999SE |
| K982931 | Threaded Fixation PinJDW · Traditional | 10/21/1998SE |
| K926237 | O'Brien GoniometerKQW · Traditional | 08/02/1993SE |
| K922292 | Lundeen Subtalar Peg ImplantMJW · Traditional | 10/23/1992SE |
| K905795 | Sgarlato Flexible Hinge Toe ImplantKWH · Traditional | 05/29/1991SE |
| K884739 | Sgarlato Lesser Toe ImplantKWH · Traditional | 05/18/1989SE |
Questions and answers
When was First MPJ Continuous Passive Motion Device cleared by the FDA?
First MPJ Continuous Passive Motion Device (K926262) received a 510(k) decision of Substantially Equivalent on January 26, 1994, 404 days after the submission was received.
What is the product code of K926262?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.