Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5410](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5410) → JFA — Exerciser, Finger, Powered

# JFA · Exerciser, Finger, Powered

_Physical Medicine · 21 CFR 890.5410 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA

## Overview

- **Product Code:** JFA
- **Device Name:** Exerciser, Finger, Powered
- **Regulation:** [21 CFR 890.5410](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5410)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945803](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K945803.md) | THERMAFLEX, MODEL SD 55 C.P.M.H. | Burke Neutech, Inc. | May 11, 1995 | SESE |
| [K931016](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K931016.md) | JACE MODEL H440 HAND CPM DEVICE | Jace Systems, Inc. | Jun 22, 1994 | SESE |
| [K933418](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K933418.md) | HAND THERAPY ASSOST | Bardon Ent., Inc. | Apr 28, 1994 | SESE |
| [K921351](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K921351.md) | JACE MODEL PM-410 HAND CPM DEVICE | Jace Systems, Inc. | May 4, 1992 | SESE |
| [K900794](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K900794.md) | MOBILIMB H3 HAND CPM UNIT | Toronto Medical Corp. | Mar 2, 1990 | SESE |
| [K900581](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K900581.md) | DANNIFLEX CPM 880(TM) | Buckman Co., Inc. | Feb 20, 1990 | SESE |
| [K880686](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K880686.md) | TORONTO/MOBILIMB HAND C.P.M. | Toronto Medical Corp. | Feb 26, 1988 | SESE |
| [K880336](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K880336.md) | MOBILIMB HAND C.P.M. UNIT | Toronto Medical Corp. | Feb 16, 1988 | SESE |
| [K860714](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K860714.md) | ACE AIM - CPM HAND UNIT | Buckman Co., Inc. | Mar 27, 1986 | SESE |
| [K844033](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K844033.md) | MOBILIMB HAND UNIT | Danninger Medical Technology, Inc. | Nov 27, 1984 | SESE |
| [K830974](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K830974.md) | SUTTER CPM 5000 | Sutter Biomedical, Inc. | Apr 12, 1983 | SESE |
| [K790527](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA/K790527.md) | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | Maddak, Inc. | Mar 22, 1979 | SESE |

## Top Applicants

- Toronto Medical Corp. — 3 clearances
- Buckman Co., Inc. — 2 clearances
- Jace Systems, Inc. — 2 clearances
- Bardon Ent., Inc. — 1 clearance
- Burke Neutech, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/JFA)

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