CC Rider, Model ME180
FDA 510(k) K951916 · Mettler Electronics Corp.
510(k) numberK951916
Submission
- Device name
- CC Rider, Model ME180
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- April 24, 1995
- Decision date
- October 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IKK – System, Isokinetic Testing And Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1925
- Specialty
- Physical Medicine
Other 510(k)s with product code IKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123746 | Ames Therapy DeviceIKK · Traditional | Ames Technology, Inc. | 05/24/2013SE |
| K952090 | Humac SystemIKK · Traditional | Computer Sports Medicine, Inc. | 12/11/1995SE |
| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | Biodex Medical Systems, Inc. | 11/16/1995SE |
| K950095 | Cybex 770IKK · Traditional | Cybex | 06/21/1995SE |
| K942229 | Motivator FTR 2000IKK · Traditional | Hogan & Hartson | 02/27/1995SE |
| K944732 | Dexter IsokineticIKK · Traditional | Cedaron Medical, Inc. | 02/03/1995SE |
| K924414 | The Bte Dynamic LiftIKK · Traditional | Baltimore Therapeutic Equipment Co. | 02/12/1993SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | Biodan Medical Systems, Ltd. | 07/23/1992SE |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | Biodan Medical Systems, Ltd. | 07/13/1992SE |
| K922092 | Single Chair Integral Back AttachmentIKK · Traditional | Biodan Medical Systems, Ltd. | 05/26/1992SE |
More from Biodan Medical Systems, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233926 | accufitIPF · Traditional | 03/21/2024SE |
| K223802 | accufitIPF · Traditional | 10/06/2023SE |
| K113017 | Sys*Stim 240IPF · Abbreviated | 06/26/2012SE |
| K111482 | Sonicator Plus 920IMG · Special | 08/25/2011SE |
| K091540 | MTD 4000ITH · Abbreviated | 10/08/2009SE |
| K071137 | Sonicator Plus 940, Model ME940IMG · Abbreviated | 08/01/2007SE |
| K053546 | Sonicator 740, Model Me 740IMI · Abbreviated | 05/04/2006SE |
| K043586 | Laser Sys*Stim 540, Model Me 540ILY · Abbreviated | 05/06/2005SE |
| K042554 | Auto Therm 390, Model Me 390IMJ · Abbreviated | 10/08/2004SE |
| K031017 | Sys*Stim 208 and 208AIPF · Traditional | 05/30/2003SE |
Questions and answers
When was CC Rider, Model ME180 cleared by the FDA?
CC Rider, Model ME180 (K951916) received a 510(k) decision of Substantially Equivalent on October 4, 1995, 163 days after the submission was received.
What is the product code of K951916?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.