Theracushion Model 1000
FDA 510(k) K861834 · General Physiotherapy, Inc.
510(k) numberK861834
Submission
- Device name
- Theracushion Model 1000
- Applicant
- General Physiotherapy, Inc.
St. Louis, MO, US - Received
- May 13, 1986
- Decision date
- May 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISA – Massager, Therapeutic, Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5660
- Specialty
- Physical Medicine
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More from Lpg One, Inc.
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|---|---|---|
| K870939 | VibracareISA · Traditional | 04/06/1987SE |
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| K855129 | Neocussor (Massager, Battery) PoweredBYI · Traditional | 01/23/1986SE |
| K853710 | TheracushionISA · Traditional | 01/03/1986SE |
| K852944 | Fleximatic MassagerISA · Traditional | 09/05/1985SE |
| K850047 | Sanyo Electronic Muscle StimulatorsIPF · Traditional | 03/05/1985SE |
| K844591 | Mist-Ease NebulizerCCQ · Traditional | 12/13/1984SE |
| K810244 | Porta-Puls Muscle StimulatorIRO · Traditional | 02/26/1981SE |
Questions and answers
When was Theracushion Model 1000 cleared by the FDA?
Theracushion Model 1000 (K861834) received a 510(k) decision of Substantially Equivalent on May 27, 1986, 14 days after the submission was received.
What is the product code of K861834?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.