# Orthosis, Limb, For Back Pain
> **Product code: PMV** · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3475
## Classification
- **FDA Product Code:** PMV
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 890.3475
- **Review panel:** PM
- **Medical specialty:** Physical Medicine
- **Submission type:** 4
- **GMP exempt:** Y
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 12
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PMV)
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